HER2-low / ultralow (IHC 1+ or 2+/ISH-)

Approved therapies

Approvals in the United States (FDA) and the European Union (EMA), one row per drug, regimen and tumour type. Open a row for the exact indication and source.

Companies

Industry sponsors leading active trials, by number of trials. Each square is one trial, shaded by phase.

1. Daiichi Sankyo 7
2. AstraZeneca 5
3. Baili-Bio / SystImmune 5
4. RemeGen 4
5. Chia Tai Tianqing 2
6. DualityBio 2
7. Jiangsu Hengrui 2
8. Pfizer 2
9. BriaCell Therapeutics 1
10. Gilead Sciences 1
11. Jiangsu Alphamab Biopharmaceuticals 1
12. SUNHO（China）BioPharmaceutical 1
13. Aston Sci 1
14. Henlius 1
15. MediLink Therapeutics (Suzhou) 1

Phase 1 Phase 2 Phase 3 Phase 4 No phase

Trials

Matched automatically from registry text, so a few trials may only mention HER2-low / ultralow (IHC 1+ or 2+/ISH-) rather than require it. Check the quoted criterion, and the registry entry before relying on a match.

124 of 168 trials shown

1. Study Aiming to Compare the Plasma Exposure of the Payload (Free-DXd) in Patients Treated by T-DXd for Locally Advanced or Metastatic Breast Cancer According to Their BMI.

   Recruiting Phase 4 Institut Claudius Regaud Started 2025 NCT07195344

   Pharmacokinetics blood samples

   …ith overexpression/amplification HER2 (IHC +++ or ++ and positive-hybridation in situ) or low HER2 expression (IHC + or ++ and negative-hybridation in situ) and may be ultra-low (in first line, in ca…

   Locally Advanced or Metastatic Breast Cancers

2. Famitinib Combined With SHR-A1811, Versus SHR-A1811 for CDK4/6 Inhibitors-resistent Advanced HR+/HER2- Breast Cancer With SNF4 Subtype

   Not yet recruiting Phase 3 Fudan University Started 2026 NCT07382687

   SHR-A1811Famitinib+SHR-A1811

   HER2 low expression or ultra-low expression \[FISH/CISH- and IHC+/++ or IHC 0 but with ≤10% of tum…

   Breast Cancer

3. Premedication With Dexamethasone for Preventing Interstitial Lung Disease in Patients With Breast Cancer Treated With Trastuzumab Deruxtecan

   Not yet recruiting Phase 3 Mario Negri Institute for Pharmacological Research Started 2026 NCT07828054

   Dexamethasoneantiemetic premedicationT-DXd

   HR-negative with expression of HER2-low ≤ 2 lines of chemotherapy in advanced disease

   Breast Cancer, Interstitial Lung Disease (ILD)

4. Megestrol Acetate for Fatigue Management in T-DXd Treated Breast Cancer

   Recruiting Phase 3 Sun Yat-sen University Started 2026 NCT07543536

   Megestrol Acetate + Trastuzumab Deruxtecan FDA EU

   HER2-positive (IHC 3+ or IHC 2+ with FISH positive), HER2-low (IHC 1+ or IHC 2+ with FISH negative), or HER2-ultralow (IHC 0 with ≤10% weak incomplete …

   Advanced/Metastatic Breast Cancer, HER2+, Low, or Ultralow Advanced/Metastatic Breast Cancer

5. A Randomized Secondary Adjuvant Treatment Intervention Study Comparing Trastuzumab-Deruxtecan to SOC Therapy in eBC Patients With Molecular Relapse

   Recruiting Phase 3 Prof. Wolfgang Janni Started 2025 NCT06643585

   Trastuzumab-Deruxtecan

   HER2-low defined as an immunohistochemistry (IHC) score of 1+ or an IHC score of 2+ with a mandato…

   Breast Cancer

6. A Study of BL-M07D1 Versus Investigator's Choice of Chemotherapy in Patients With HER2-low Recurrent/Metastatic Breast Cancer

   Recruiting Phase 3 Baili-Bio / SystImmune Started 2025 NCT06957886

   BL-M07D1Capecitabine, Eribulin, Gemcitabine, Paclitaxel, or Albumin paclitaxel

   Histologically or cytologically confirmed unresectable, locally recurrent or metastatic HER2-low breast cancer;

   HER2-low Breast Cancer

7. A Study of Disitamab Vedotin Combined With Tislelizumab and Chemotherapy Versus Tislelizumab Combined With Chemotherapy in HER2-Low Advanced Gastric or Gastroesophageal Junction Adenocarcinoma

   Not yet recruiting Phase 3 RemeGen Started 2025 NCT06944496

   Disitamab Vedotin+Tislelizumab+Oxaliplatin+CapecitabineTislelizumab+Oxaliplatin+Capecitabine

   HER2-low expression

   Gastric Carcinoma

8. Neoadjuvant Pyrotinib in HR-positive and HER2-low High-risk Early Breast Cancer

   Active, not recruiting Phase 3 Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University Started 2024 NCT06144944

   Pyrotinib, epirubicin or doxorubicin, cyclophosphamide, paclitaxelEpirubicin or doxorubicin, cyclophosphamide, paclitaxel

   …eceptor-positve ( estrogen receptor and/or progesterone receptor ≥ 10% stained cells) and HER2-low (immunochemistry 2+ with fluorescent in situ hybridization negative)

   Breast Cancer Invasive, Hormone-receptor-positive Breast Cancer, HER2 Low Breast Carcinoma, Early-stage Breast Cancer

9. A Study of DB-1303/BNT323 vs Investigator's Choice Chemotherapy in HER2-Low, Hormone Receptor Positive Metastatic Breast Cancer (DYNASTY-Breast02)

   Active, not recruiting Phase 3 DualityBio Started 2024 NCT06018337

   DB-1303/BNT323CapecitabinePaclitaxelNab-paclitaxel

   Has HER2-low expression (IHC 1+ or IHC 2+/ISH-) as determined by the central laboratory result.

   Metastatic Breast Cancer

10. A Clinical Trial of TQB2102 for Injection in the Treatment of HER2 Low-Expressing Recurrent/Metastatic Breast Cancer

    Active, not recruiting Phase 3 Chia Tai Tianqing Started 2024 NCT06561607

    TQB2102 for InjectionChemotherapy drug (Capecitabine/Paclitaxel/Albumin Paclitaxel)

    Pathologically confirmed locally advanced or metastatic breast cancer with low HER2 expression and unresectable:

    Breast Cancer

11. To Evaluate IAH0968 in Combination With CAPEOX in HER2-positive Gastric Cancer

    Recruiting Phase 2/3 SUNHO（China）BioPharmaceutical Started 2024 NCT06504732

    IAH0968Trastuzumab Injection

    and HER2 low expression (IHC 2+ and FISH-, or IHC 1+) demonstrated by immunohistochemical (IHC) staini…

    Stomach Neoplasms, Solid Tumor

12. Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Patients With Hormone Receptor-positive/Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2-) Metastatic Breast Cancer Who Have Received Endocrine Therapy

    Active, not recruiting Phase 3 Gilead Sciences Started 2023 NCT05840211

    Sacituzumab Govitecan-hziyPaclitaxelNab-paclitaxelCapecitabine

    …or-Positive (HR+)/Human Epidermal Growth Factor Receptor 2 Negative (HER2-) (HER2 IHC0 or HER2-low [IHC 1+, IHC 2+/ISH-]) Inoperable, Locally Advanced, or Metastatic Breast Cancer and Have…

    Locally Advanced or Unresectable Metastatic Breast Cancer, Stage IV Breast Cancer

13. Disitamab Vedotin (RC48) in Hormone Receptor Positive, HER2-low Metastatic Breast Cancer (the Rosy Trial)

    Recruiting Phase 3 Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University Started 2023 NCT05904964

    Disitamab vedotin

    HER2-low: immunohistochemical staining of 2 + and FISH is not expanded, IHC 1 +);

    Status may be outdated, last updated 2023-06-22HR Positive/HER2 Low Expression Metastatic Breast Cancer

14. JSKN003 Versus Treatment Of Physician'S Choice For HER2-low, Unresectable and/or Metastatic Breast Cancer Subjects

    Recruiting Phase 3 Jiangsu Alphamab Biopharmaceuticals Started 2023 NCT06079983

    JSKN003Capecitabine tabletsGemcitabine hydrochloride for injectionVinorelbine tartrate injectionPaclitaxel for injection (albumin-bound type)Docetaxel injection

    JSKN003 Versus Treatment Of Physician'S Choice For HER2-low, Unresectable and/or Metastatic Breast Cancer Subjects

    Breast Cancer

15. SHR-A1811 Versus Investigator's Chemotherapy in Recurrent/Metastatic Breast Cancer Clinical Trial

    Active, not recruiting Phase 3 Jiangsu Hengrui Started 2023 NCT05814354

    SHR-A1811Capecitabine/Eribulin/Gemcitabine/Paclitaxel/Nab-paclitaxel

    Low-HER2 expression defined as IHC 2+/ISH- or IHC 1+ (ISH- or untested).

    Breast Cancer

16. Study of the Bria-IMT Regimen and CPI vs Physicians' Choice in Advanced Metastatic Breast Cancer.

    Recruiting Phase 3 BriaCell Therapeutics Started 2023 NCT06072612

    SV-BR-1-GMCyclophosphamideInterferon infiltration of the inoculation siteRetifanlimabTreatment of Physician's Choice

    HER2 low patients, in addition to the appropriate therapies based on ER/PR status and germline or …

    Breast Cancer, Metastatic Breast Cancer, Breast Neoplasm, Breast Cancer Metastatic

17. Trastuzumab Deruxtecan (T-DXd) in Patients Who Have Hormone Receptor-negative and Hormone Receptor-positive HER2-low or HER2 IHC 0 Metastatic Breast Cancer

    Recruiting Phase 3 Daiichi Sankyo Started 2023 NCT05950945

    Trastuzumab Deruxtecan FDA EU

    In participants with hormone receptor-positive HER2-low metastatic BC (Cohort 3):

    Breast Cancer

18. Study of Trastuzumab Deruxtecan (T-DXd) vs Investigator's Choice Chemotherapy in HER2-low, Hormone Receptor Positive, Metastatic Breast Cancer

    Active, not recruiting Phase 3 AstraZeneca Started 2020 NCT04494425

    Trastuzumab deruxtecan FDA EUCapecitabinePaclitaxelNab-Paclitaxel

    3. has HER2-low or HER2 IHC \>0 \<1+ expression as determined by the central laboratory result establishe…

    Advanced or Metastatic Breast Cancer

19. Phase II Study of Trastuzumab Rezetecan Combined With Adebrelimab and Lenvatinib as First-Line Therapy for Advanced HER2-Positive/HER2-Low Biliary Tract Cancer

    Recruiting Phase 2 Peking Union Medical College Hospital Started 2026 NCT07670273

    Trastuzumab RezetecanAdebrelimabLenvatinib

    HER2 positive (IHC 3+ or IHC 2+ and FISH detects HER2/CEP17 ≥ 2.0), HER2 low expression (IHC 2+/FISH- or IHC 1+);

    Biliary Tract Neoplasms Immunotherapy

20. The Efficacy and Safety of Trastuzumab Rezetecan (SHR-A1811) in HER2-Low Unresectable/Metastatic Breast Cancer Patients With Visceral Crisis

    Recruiting Phase 2 Cancer Institute and Hospital, Chinese Academy of Medical Sciences Started 2026 NCT07203729

    Trastuzumab RezetecanChemotherapy of Physician's Choice

    Pathologically confirmed HER2-Low unresectable or metastatic breast cancer;

    HER2-Low Unresectable/Metastatic Breast Cancer Complicated With Visceral Crisis

21. Study of Trastuzumab Deruxtecan (T-DXd) in Combination With a RAGE Inhibitor in Patients With T-DXd-Resistant HER2-Positive or HER2-Low Metastatic Breast Cancer

    Not yet recruiting Phase 1/2 The Methodist Hospital Research Institute Started 2026 NCT07785856

    AzeliragonT-DXd

    Histologically confirmed HER2-positive or HER2-low or ultra low metastatic breast cancer.

    T-dxd Resistant HER2-Positive, HER2 Low Metastatic Breast Cancer

22. Testing Two Different Drugs (Sacituzumab-govitecan and Trastuzumab-deruxtecan) Combinations Prescribed in an Alterning Pattern to Patients With Metastatic or Locally Advanced Triple-negative Breast Cancer

    Not yet recruiting Phase 2 UNICANCER Started 2026 NCT07151586

    Sacituzumab Govitecan / Trastuzumab Deruxtecan FDA EU

    HER2-low breast cancer, defined as either immunohistochemistry (IHC) 2+ / in situ hybridization (I…

    Triple Negative Breast Neoplasms, Neoplasm Metastasis, HER 2 Low-expressing Breast Cancer

23. Neoadjuvant Therapy Combined With Trastuzumab Rezetecan and Toripalimab for HR+/HER2-low Breast Cancer (NEOTORCH-BREAST 08)

    Recruiting Phase 2 First Affiliated Hospital of Zhejiang University Started 2026 NCT07383818

    Neoadjuvant therapy combined with Trastuzumab Rezetecan and ToripalimabNeoadjuvant Chemotherapy in Combination with ToripalimabNeoadjuvant Chemotherapy

    All patients must be pathohistologically confirmed as HR-positive/HER2-low.

    HR Positive/HER2 Low Breast Cancer

24. A Cancer Vaccine (STEMVAC) in Combination With Chemotherapy for the Treatment of PD-L1 Negative Metastatic Triple-Negative Breast Cancer

    Recruiting Phase 2 University of Washington Started 2026 NCT07078604

    CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope Plasmid DNA VaccineChemotherapySargramostim

    HER2-negative or HER2-low will be defined by the American Society of Clinical Oncology (ASCO)/College of American P…

    Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Triple-Negative Breast Carcinoma

25. A Phase Ib/II Study Evaluating Injectable ALK-N001 in Patients With Advanced Solid Tumors

    Not yet recruiting Phase 1/2 Zhejiang Anglikang Pharmaceutical Started 2026 NCT07509684

    ALK-N001 for Injection

    … cancer, esophageal cancer, liver cancer, breast cancer (triple-negative breast cancer or HER2 low/ultra-low expression breast cancer), ovarian cancer, cervical cancer, and other tumor typ…

    Advanced Solid Tumors

26. A Study of Patritumab Deruxtecan (HER3-DXd) in Combination With Trastuzumab Deruxtecan (T-DXd) in Participants With HR-Positive, HER2-Low or HER2-Ultralow Unresectable or Metastatic Breast Cancer

    Recruiting Phase 1/2 Daiichi Sankyo Started 2026 NCT07701941

    Patritumab deruxtecanTrastuzumab deruxtecan FDA EU

    Assessed as HER2-low (defined as Immunohistochemistry (IHC)2+/In-situ hybridization (ISH)- or IHC1+) or HER2-u…

    Hormone Receptor Positive, HER2-low or HER2-ultralow, Unresectable or Metastatic Breast Cancer

27. Neoadjuvant Dalpiciclib + AI → SHR-A1811 for HR+/HER2-Low Breast Cancer

    Not yet recruiting Phase 2 Tang-Du Hospital Started 2026 NCT07618923

    Dalpiciclib 125mgAromatase InhibitorSHR-A1811

    Histologically confirmed invasive breast cancer, HR+ (ER ≥1% and/or PR ≥1%) and HER2-low (IHC 1+ or IHC 2+/ISH-)

    Breast Cancer, HR Positive/HER2 Low Breast Cancer

28. ARX788 for Treating Patients With HER2-low Locally Advanced Unresectable or Metastatic Breast Cancer

    Recruiting Phase 2 Laura Huppert, MD, BA Started 2026 NCT06224673

    ARX788Amiloride

    Pathologically documented HER2-low locally advanced unresectable or metastatic breast cancer (MBC).

    HER2 Low Breast Carcinoma, Triple Negative Breast Cancer, Hormone-receptor-positive Breast Cancer, Hormone Receptor Positive Breast Carcinoma

29. A Phase II Study of SSGJ-612 Plus a HER2-Targeted ADC in HR-Positive, HER2-Low or HER2-Ultralow Expression Metastatic Breast Cancer

    Recruiting Phase 2 Shenyang Sunshine Pharmaceutical Started 2026 NCT07757230

    SSGJ-612 (HER2-targeted antibody)HER2-targeted ADC

    Tumor samples tested by central laboratory confirmed as HER2-low or HER2 ultra-low expression;

    Metastatic Breast Cancer

30. Conversion Therapy With Retlirafusp Alfa Plus Chemotherapy in Gastric or Gastroesophageal Junction Adenocarcinoma

    Not yet recruiting Phase 2 Tang-Du Hospital Started 2026 NCT07709767

    Retlirafusp AlfaOxaliplatinCapecitabine

    HER2-low, HER2-intermediate, or HER2-negative disease, and PD-L1 CPS ≥1.

    Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma

31. A Trial of Trastuzumab Rezetecan in Unresectable Locally Recurrent/Metastatic Breast Cancer

    Recruiting Phase 2 Jiangsu Hengrui Started 2026 NCT07497386

    Trastuzumab Rezetecan for InjectionTrastuzumab Deruxtecan for Injection FDA EU

    …Treatment of Unresectable Locally Recurrent/Metastatic Breast Cancer With HR-Positive and HER2-Low Expression

    Unresectable Locally Recurrent Breast Cancer, Unresectable Locally Metastatic Breast Cancer

32. Sequencing SG vs. T-DXd in HER2-Low/TROP2-High Metastatic Breast Cancer

    Not yet recruiting Phase 2 Fudan University Started 2026 NCT07368543

    Sacituzumab GovitecanTrastuzumab Deruxtecan FDA EU

    …etastatic breast cancer that is:HER2 IHC 1+ triple-negative breast cancer, or HR-positive/HER2-ultralow or HER2 IHC 1+ breast cancer.

    Metastatic Breast Cancer

33. Phase II Study of Trastuzumab Rezetecan Combined With Adebrelimab and Lenvatinib in Advanced HER2-Positive/Low-Expression Biliary Tract Cancer

    Recruiting Phase 2 Peking Union Medical College Hospital Started 2026 NCT07704177

    Trastuzumab RezetecanAdebrelimabLenvatinib

    HER2 positive (IHC 3+ or IHC 2+ and FISH detects HER2/CEP17 ≥ 2.0), HER2 low expression (IHC 2+/FISH- or IHC 1+)

    Biliary Tract Neoplasms Immunotherapy

34. First-line Therapy With Epidermal Growth Factor Receptor-Tyrosine Kinase Inhibitor(EGFR-TKI) Combined With Trastuzumab Rezetecan for Advanced Non-small Cell Lung Cancer(NSCLC) Harboring EGFR Mutations Concomitant With Human Epidermal Growth Factor Receptor 2(HER2) Alterations

    Not yet recruiting Phase 2 Yongsheng Wang Started 2026 NCT07699952

    AlmonertinibTrastuzumab Rezetecan

    HER2 low expression or overexpression by immunohistochemistry (IHC 1+/2+/3+);

    Lung Cancer (NSCLC), EGFR Activating Mutation, HER2

35. Trastuzumab Deruxtecan and Lovastatin in HER2-low and Ultralow Advanced or Metastatic Breast Cancer

    Not yet recruiting Phase 2 Washington University School of Medicine Started 2026 NCT07619365

    Trastuzumab deruxtecan FDA EULovastatin

    Histologically or cytologically confirmed HER2 low (IHC 1+ or 2+ with negative in-situ hybridization) or ultralow (IHC 0 with incomplete/fai…

    Breast Cancer, Advanced Breast Cancer, Metastatic Breast Cancer

36. Phase II Study of SHR-A1811 for Ultra-Low HER2 Advanced Breast Cancer

    Recruiting Phase 2 Tianjin Medical University Cancer Institute and Hospital Started 2026 NCT07817082

    SHR- A1811

    History of ultra-low HER2 expression: histopathology confirms ultra-low HER2 expression, defined as incomplete, faint membrano…

    Advanced Breast Cancer With Ultra-Low HER2 Expression

37. Trastuzumab Deruxtecan Plus ivonescImab for Hormone Receptor-positive HER2 Negative Advanced Breast Cancer Study

    Recruiting Phase 2 Fudan University Started 2026 NCT07647016

    Trastuzumab Deruxtecan and ivonescimab FDA EU

    …y confirmed Hormone Receptor-positive (HR+) and Human Epidermal Growth Factor Receptor 2 (HER2)-low or HER2-ultralow breast cancer, with evidence of locally recurrent or metastatic disease …

    Breast Cancer

38. A Study Comparing BL-M07D1 With DS-8201 in Patients With HR-Positive, HER2-Low Expressing Recurrent/Metastatic Breast Cancer

    Recruiting Phase 2 Baili-Bio / SystImmune Started 2026 NCT07678957

    BL-M07D1DS-8201

    Locally recurrent or metastatic breast cancer that is hormone receptor (HR)-positive and HER2-low expressing；

    Breast Cancer

39. Clinical Studies of TQB2930 Injection for the Treatment of Advanced Solid Tumors

    Recruiting Phase 1/2 Chia Tai Tianqing Started 2026 NCT07512583

    TQB2930 injection+TQB2102 for injection

    …ncludes HER2 positive (including Immunohistochemistry (IHC) 3+, IHC 2+and Fish positive), HER2 low expression (including IHC 1+ IHC 2+and Fish negative, HC 0 but with HER2 expression);

    Advanced Solid Tumor

40. A Study of Trastuzumab Deruxtecan (T-DXd) and Cetuximab in People With Colorectal Cancer

    Not yet recruiting Phase 2 Memorial Sloan Kettering Cancer Center Started 2026 NCT07691489

    Fam-Trastuzumab Deruxtecan-Nxki FDA EU

    A Phase 2 Trial of Trastuzumab Deruxtecan in Combination With Cetuximab in HER2-low Metastatic Colorectal Cancer That Has Progressed on Standard Therapies

    Colorectal Cancer, Adenocarcinoma of the Colon, Adenocarcinoma of the Rectum

41. Chemotherapy With or Without Adebrelimab and T-DXh as Neoadjuvant Therapy for HR+/HER2 Low Early Stage Breast Cancer

    Not yet recruiting Phase 2 Cancer Institute and Hospital, Chinese Academy of Medical Sciences Started 2026 NCT07317778

    SHR-A1811Adebrelimab (PD-L1 inhibitor)Taxane ChemotherapyAnthracycline & Cyclophosphamide treatment scheme

    HR positive/HER2 low expression(defined as HER2 IHC 1+/2+, FISH negative);

    Breast Cancer Early Stage Breast Cancer (Stage 1-3), HR Positive/HER2 Low Breast Cancer

42. Efficacy and Safety Study of Disitamab Vedotin + RC148 vs. Albumin-Paclitaxone ± Toripalimab in HR-/HER2-low Breast Cancer

    Recruiting Phase 2 RemeGen Started 2025 NCT06642545

    Disitamab VedotinRC148Albumin-bound PaclitaxoneToripalimab

    Invasive breast tumor tissue has been confirmed as HER2 low expression by the central laboratory

    Breast Cancer

43. A Clinical Study to Find the Optimal Dose of an Investigational Treatment Called BNT323 When Used in Combination With Another Investigational Treatment, BNT327, and to Test if That Combination Treatment is Safe and Beneficial for Patients With Advanced Breast Cancer

    Recruiting Phase 1/2 BioNTech Started 2025 NCT06827236

    BNT323BNT327

    …s a documented history of HER2 expression consistent with the subgroup definitions (i.e., HER2-low, HER2-ultralow, HER2-null, HER2-positive, or TNBC) as per current American Society of Cli…

    Locally Advanced Breast Cancer, Unresectable Breast Carcinoma, Metastatic Breast Cancer

44. A Phase II Study of HLX22 in Combination With Trastuzumab Deruxtecan in HER2-low, Hormone Receptor Positive Locally Advanced or Metastatic Breast Cancer Patients

    Recruiting Phase 2 Henlius Started 2025 NCT06832202

    HLX22Trastuzumab Deruxtecan FDA EU

    With histologically confirmed diagnosis of HER2-low, Hormone Receptor Positive Locally Advanced or Metastatic Breast Cancer.

    HER2-low Hormone Receptor Positive Breast Cancer

45. Genomic and Transcriptomic Predictors of Sequential SG Sensitivity After T-DXd in ER+/HER2-Low Metastatic Breast Cancer

    Recruiting Phase 2 British Columbia Cancer Agency Started 2025 NCT06665178

    Sacituzumab Govitecan

    Patients with locally advanced or metastatic ER+/HER2 low (defined as IHC 1+ or 2+ but FISH or CISH negative by ratio as per ASCO/CAP guidelines) b…

    Breast Cancer

46. Safety and Efficacy of T-DXd vs. CDK4/6i-based ET as First-line Therapy of HR-positive and HER2-low/Ultralow Advanced Breast Cancer Patients Classified as Non-luminal Subtype

    Recruiting Phase 2 MedSIR Started 2025 NCT06486883

    Trastuzumab deruxtecan (T-DXd, DS-8201a) FDA EUCDK4/6i plus ET

    Evidence of HER2-low expression (1+ by immunohistochemistry (IHC) or 2+ and negative by an in situ hybridizati…

    Advanced Breast Cancer, Advanced Breast Carcinoma, Hormone Receptor Positive Breast Carcinoma

47. Efficacy and Safety of Trastuzumab Rezetecan Followed by CDK4/6 Inhibitors and Endocrine Therapy in HR+/HER2-Low/Ultra-Low Advanced Breast Cancer

    Recruiting Phase 2 Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University Started 2025 NCT07037199

    Trastuzumab rezetecan + CDK4/6 inhibitors + endocrine therapy

    Pathologically confirmed HER2-low/ultra-low, HR-positive unresectable or metastatic breast cancer:

    Advanced Breast Cancer

48. A Vaccine (STEMVAC) With Standard Endocrine-Based Therapy or Chemotherapy for the Treatment of Metastatic Hormone Receptor Positive, HER2 Negative Breast Cancer

    Recruiting Phase 2 University of Washington Started 2025 NCT07112053

    CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope Plasmid DNA VaccineCapecitabineCyclin-Dependent Kinase 4 InhibitorCyclin-Dependent Kinase 6 InhibitorF-18 16 Alpha-FluoroestradiolHormone Therapy

    HER2-negative or HER2-low will be included and defined as:

    Anatomic Stage IV Breast Cancer AJCC v8, Metastatic HER2-Negative Breast Carcinoma, Metastatic Hormone Receptor-Positive Breast Carcinoma

49. A Study of Disitamab Vedotin in Adults With HER2 Expressing Advanced Breast Cancer

    Active, not recruiting Phase 1/2 Pfizer Started 2025 NCT06966453

    Disitamab vedotin

    HER2-low: IHC 1+/ISH-negative or untested or IHC 2+/ISH-negative

    Breast Cancer, Breast Neoplasms

50. DB-1311 in Combination With BNT327 or DB-1305 in Advanced/Metastatic Solid Tumors

    Recruiting Phase 2 DualityBio Started 2025 NCT06953089

    DB-1311/BNT324BNT327DB-1305/BNT325

    HR+/HER2-low or HR+/HER2-ultralow or HR+/HER2-negative BC participants: Pathologically or cytologicall…

    Solid Tumors

51. Detecting Tumor DNA in the Blood of HR+/HER2-low Metastatic Breast Cancer Patients to Find Candidates for T-DXd Therapy

    Enrolling by invitation Phase 2 UNICANCER Started 2025 NCT06680596

    trastuzumab derxutecan

    Is HER2 low (HER2 1+, or 2+ and in situ hybridization (ISH) negative) or HER2 ultra low (IHC 0 with i…

    Breast Cancer Metastatic, Breast Cancer Stage IV

52. Clinical Study of SHR-A1811 With or Without Letrozole in Neoadjuvant Therapy for Early-Stage HR-Positive, HER2-Low Breast Cancer

    Not yet recruiting Phase 2 First Hospital of China Medical University Started 2025 NCT07305246

    SHR-A1811LetrozoleTAC/AC-T

    Histopathologically confirmed HR-positive (ER ≥1% and/or PR ≥1%) with HER2-low expression (defined as IHC 1+/2+ and FISH negative);

    Breast Cancer

53. SHR-1811 Combined With Carboplatin in the Treatment of Advanced Breast Cancer With HER2 Expression

    Not yet recruiting Phase 2 Anhui Provincial Cancer Hospital Started 2025 NCT07047443

    SHR- A1811

    Unresectable or metastatic breast cancer with HER2 positive (IHC 3+ or IHC 2+/ISH+), low HER2 expression (IHC 1+ or IHC 2+/ISH-), or ultra-low HER2 expression (IHC 0 with membrane staining) conf…

    Breast Cancer

54. T-DXd With or Without Bevacizumab for HER2-low Breast Cancer With Brain Metastasis

    Recruiting Phase 2 Fudan University Started 2025 NCT07150208

    Bevacizumab (Bev)Trastuzumab Deruxtecan (T-DXd) FDA EU

    Histologically confirmed invasive HER2-low expressing breast cancer (specific definition: breast cancer patients with low expression…

    Breast Cancer With Brain Metastasis, HER2-low Expressing Breast Cancer

55. A Phase II Study of SHR-A1811 Combined With Radiotherapy in HER2-positive and HER2-low Breast Cancer Brain Metastases

    Not yet recruiting Phase 2 Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Started 2025 NCT06975462

    SHR-A1811 and radiotherapy

    Pathologically confirmed HER2 positive (IHC 3+ or IHC 2+/FISH+)or HER2-low(IHC1+ or 2+/FISH-) advanced breast cancer

    Breast Cancer Metastatic

56. ERADICATE: A Phase Ib/II Study of Elacestrant Plus Trastuzumab Deruxtecan in Patients With CDK4/6 Inhibitor and Endocrine-resistant HR+/HER2-low or HER2-ultralow Metastatic Breast Cancer

    Recruiting Phase 1/2 Kristina A. Fanucci Started 2025 NCT07198724

    ElacestrantTrastuzumab Deruxtecan FDA EU

    Participants must have a histologically or cytologically confirmed diagnosis of HR+/HER2-low metastatic or unresectable locally advanced breast cancer, defined as ER ≥ 10%, any PR in…

    Metastatic Breast Cancer, HER2 Low Breast Carcinoma, HER2-negative Breast Cancer, Breast Cancer

57. Phase 1/2 Dose Finding, Safety and PK Study in Advanced Refractory Solid Tumors

    Recruiting Phase 1/2 MBrace Therapeutics Started 2025 NCT07145255

    ADC

    i. mCRPC, breast cancer (TNBC, HR+/HER2-negative or HER2-low, HR-/HER2+), CRC, NSCLC, or PDAC

    Prostate Cancer Castration-resistant Prostate Cancer, Breast Cancer, Colo-rectal Cancer, Lung Cancer (Non-Small Cell)

58. A Study Evaluating the Efficacy and Safety of De Trastuzumab (T-DXd) in Combination with Immunotherapy for the Neoadjuvant Treatment of HR-positive HER2 Low-expressing Chinese Patients with Early-stage Breast Cancer

    Not yet recruiting Phase 2 Guangzhou Women and Children's Medical Center Started 2025 NCT06733233

    T-DXd combined with immune checkpoint inhibitor

    …ab (T-DXd) in Combination with Immunotherapy for the Neoadjuvant Treatment of HR-positive HER2 Low-expressing Chinese Patients with Early-stage Breast Cancer

    Breast Cancer, Estrogen Receptor-Positive, HER2 Low Breast Cancer

59. HER2-PET Imaging in HER2-low Breast Cancers

    Recruiting Phase 1/2 Centre de recherche du Centre hospitalier universitaire de Sherbrooke Started 2024 NCT06732336

    HER2-low metastatic breast cancer;

    Breast Cancer Metastatic

60. SHR-A1811 Alone or in Combination With Adebrelimab as Neoadjuvant Treatment in HR Positive/HER2 Low Breast Cancer

    Recruiting Phase 2 Shengjing Hospital Started 2024 NCT06340230

    SHR-A1811 Injection + Adebrelimab InjectionSHR-A1811 Injection + Adebrelimab InjectionSHR-A1811 Injection

    Histologically confirmed to be HR+/HER2-Low invasive breast cancer

    HR Positive/HER2 Low Breast Cancer

61. Dose-Expansion Modular Study To Explore the Safety, Tolerability, and Anti-tumor Activity of HER3- DXd Monotherapy and Combinations in Patients With Inoperable Advanced Breast Cancer (ABC) After Progression on T-DXd

    Recruiting Phase 1/2 Gustave Roussy, Cancer Campus, Grand Paris Started 2024 NCT06298084

    Patritumab deruxtecanOlaparib

    Patients with HER2-low tumors must have been treated with taxanes.

    Breast Cancer Metastatic, HER2-positive Metastatic Breast Cancer, HER2 Low Breast Carcinoma, Advanced Breast Cancer

62. Disitamab Vedotin Plus Bevacizumab in HER2-Low Metastatic Breast Cancer After T-DXd Failure: A Phase II Study

    Recruiting Phase 2 The First Affiliated Hospital with Nanjing Medical University Started 2024 NCT07446452

    Disitamab Vedotin (RC48)Bevacizumab

    Histologically or cytologically confirmed advanced or recurrent/metastatic HER2-low breast cancer (IHC 1+ or IHC 2+/ISH-).

    HER2-low Breast Cancer

63. A Study to Evaluate the Efficacy and Safety of Ifinatamab Deruxtecan (I-DXd) in Subjects With Recurrent or Metastatic Solid Tumors (IDeate-PanTumor02)

    Recruiting Phase 1/2 Daiichi Sankyo Started 2024 NCT06330064

    Ifinatamab deruxtecan

    for HER2-Low BC Participants

    Recurrent or Metastatic Solid Tumors

64. A Study of Disitamab Vedotin With Other Anticancer Drugs in Solid Tumors

    Active, not recruiting Phase 2 Pfizer Started 2024 NCT06157892

    disitamab vedotintucatinib

    Cohort A (HER2-Low Breast Cancer) Inclusion Criteria

    Breast Neoplasms, Gastroesophageal Junction Adenocarcinoma, HER2 Low Breast Neoplasms, HER2 Positive Breast Neoplasms

65. Trastuzumab Deruxtecan(T-DXd) and Afatinib Combination in HER2-low Advanced Gastric Cancer

    Recruiting Phase 1/2 Jeeyun Lee Started 2024 NCT06085755

    Trastuzumab deruxtecan FDA EUAfatinib

    HER2-low (HER2 1+, HER2 2+ (SISH negative))

    Stomach Neoplasm

66. TReatment of ADC-Refractory Breast CancEr With Dato-DXd or T-DXd: TRADE DXd

    Recruiting Phase 2 Ana C Garrido-Castro, MD Started 2024 NCT06533826

    Trastuzumab Deruxtecan FDA EUDatopotamab Deruxtecan

    Participants must have history of HER2-low or HER2-0 breast cancer per local testing, and no known history of HER2-positive breast c…

    Breast Cancer, HER2-low Breast Cancer, Metastatic Breast Cancer, HER2-negative Breast Cancer

67. A Study of GQ1010 in Subjects With Advanced Solid Tumors

    Recruiting Phase 1/2 GeneQuantum Healthcare (Suzhou) Started 2024 NCT06464055

    Dose EscalationDose Expansion1Dose Expansion2Dose Expansion3phase II

    Subjects with HER2 low expression who have progressed after treatment with anti-HER2-ADC (such as T-DXd) are adm…

    Advanced Malignant Solid Tumors

68. Chidamide and PD-1 Inhibitor Plus Anlotinib for HER2-low Breast Cancer That Has Spread or Cannot be Surgically Removed

    Not yet recruiting Phase 2 Guangdong Provincial People's Hospital Started 2024 NCT06547476

    Tucidinostat (chidamide), PD-1 inhibitor (tislelizumab), anlotinib

    Has low-HER2 expression defined as IHC 2+/ISH- or IHC 1+ (ISH- or untested)

    Status may be outdated, last updated 2024-08-09Breast Cancer

69. Cadonilimab Combination Regimen as First-line Treatment for HER2-expressing GC/GEJ Patients

    Recruiting Phase 1/2 Zhejiang Cancer Hospital Started 2024 NCT06650332

    cadonilimabTrastuzumabXELOXDisitamab VedotinmFOLFOX6

    Cohort 3: HER2 low expression, defined as IHC 1+ or IHC 2+ but ISH or FISH negative.

    Status may be outdated, last updated 2024-10-21Metastatic HER2 Positive Gastroesophageal Junction Cancer

70. To Evaluate the Efficacy and Safety of Disitamab Vedotin Combined With Toripalimab Sequential Chemotherapy as Neoadjuvant Treatment in Patients With HR-positive, HER2-low Breast Cancer

    Recruiting Phase 2 RemeGen Started 2024 NCT06389006

    Disitamab Vedotin for InjectionToripalimabEpirubicinCyclophosphamide

    Invasive breast tumor tissue with low HER2 expression confirmed by the central laboratory is defined as IHC 1+ or IHC 2+ expression of HER2 pro…

    Status may be outdated, last updated 2024-05-23Breast Cancer

71. Predicting Response to Neoadjuvant Endocrine Therapy (Neo-PREDICT)

    Recruiting Phase 2 George Washington University Started 2024 NCT06806930

    Neoadjuvant endocrine therapyNeoadjuvant endocrine therapyNeoadjuvant endocrine therapy

    HER2 negative or HER2 low breast cancer based on the most recent tumor biopsy and documented by a local laboratory …

    Breast Cancer Stage I, Breast Cancer Stage II, Breast Cancer Stage III, Carcinoma, Breast

72. T-DXd Therapy for HER2-low Breast Cancer Patients With Brain Metastases

    Active, not recruiting Phase 2 MedSIR Started 2024 NCT06048718

    Trastuzumab-Deruxtecan (T-DXd)

    T-DXd Therapy for HER2-low Breast Cancer Patients With Brain Metastases

    Breast Cancer, Metastatic Breast Cancer

73. Sequencing Antibody Drug Conjugates in ER+/HER2 LOW/ULTRA LOW MBC

    Recruiting Phase 2 Reshma L. Mahtani, D.O. Started 2024 NCT06263543

    Sacituzumab govitecan

    Histologically confirmed metastatic or advanced and unresectable breast cancer that is HER2 LOW/ULTRA LOW by local testing on either the primary or any metastatic site.

    Breast Cancer, Metastatic Breast Cancer, Advanced Breast Cancer, Hormone-receptor-positive Breast Cancer

74. A Phase 2 Study to Evaluate the Efficacy, Safety and Pharmacokinetics of YL202 in Patients With BC

    Recruiting Phase 2 MediLink Therapeutics (Suzhou) Started 2024 NCT06439771

    YL202 should be intravenously infused

    Patients who are confirmed HR positive and HER2-Zero-expression and HER2-Low-expression.

    Locally Advanced or Metastatic Breast Cancer

75. T-Dxd in Combination With Ramucirumab as HER2 Low Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma

    Recruiting Phase 1/2 Yonsei University Started 2024 NCT05894824

    T-Dxd(Trastuzmab deruxtecan), Ramucirumab

    Histologically or cytologically proven metastatic or locally advanced HER2 low gastric or GEJ adenocarcinoma: The definition of HER2 low is 1+ by immunohistochemistry (…

    Gastric Cancer, Gastroesophageal Junction (GEJ) Cancer

76. Trastuzumab Deruxtecan vs Endocrine Therapy in Low-HER2 HR+ Advanced Breast Cancer

    Recruiting Phase 2 Yonsei University Started 2023 NCT06837792

    Experimental treatment armControl treatment arm

    …hase II Study of Trastuzumab Deruxtecan Versus Endocrine Therapy of Physician's Choice in Low-HER2 Expressing Hormone Receptor-positive Advanced Breast Cancer Patients

    Hormone Receptor(HR)-Positive, Low HER2 Advanced Breast Cancer Patients (HER2 IHC 1+ or 2+ & ISH Negative)

77. A Study to Investigate the Safety, Tolerability, Pharmacokinetics (PK), and Preliminary Anticancer Activity of GSK4524101 Alone or With Niraparib in Participants With Solid Tumors

    Active, not recruiting Phase 1/2 GSK Started 2023 NCT06077877

    GSK4524101Niraparib

    Participant has metastatic, gBRCAmut, HER2-negative or HER2-low breast cancer who has completed at most 3 or more prior lines of therapy (Part 2).

    Neoplasms

78. TRUDI: TDXD+Durva in HER2+/Low IBC

    Recruiting Phase 2 Filipa Lynce, MD Started 2023 NCT05795101

    Trastuzumab deruxtecan FDA EUDurvalumab

    HER2-positive status as determined locally by the current ASCO/CAP guidelines or HER2-low tumor expression (IHC 2+/ISH-, IHC 1+/ISH-, or IHC 1+/ISH untested) (note: ISH may be det…

    Invasive Breast Cancer, Inflammatory Breast Cancer Stage III, HER2-positive Breast Cancer, HER2 Low Breast Adenocarcinoma

79. Trastuzumab Deruxtecan (T-DXd) for People With Brain Cancer

    Recruiting Phase 2 Memorial Sloan Kettering Cancer Center Started 2023 NCT06058988

    Trastuzumab deruxtecan FDA EU

    Her2-low defined as IHC1+ or 2+ and ISH- according to ASCO-CAP 2018 Her2 testing guidelines52

    Brain Cancer, Glioblastoma, Metastatic Cancer, Leptomeningeal Metastasis

80. Study of SHR-A1811 in HER2-expression Advanced Breast Cancer With Brain Metastases

    Recruiting Phase 2 Henan Cancer Hospital Started 2023 NCT05769010

    SHR-A1811PyrotinibBevacizumabAdebelizumab

    Pathologically confirmed HER2-positive or HER2-low advanced breast cancer;

    Metastatic Breast Cancer

81. Neoadjuvant Study of DV in Combination Toripalimab or Sequence Chemotherapy in HR-negative, HER2 Low-expressing Breast Cancer

    Recruiting Phase 2 RemeGen Started 2023 NCT06227117

    Disitamab Vedotin Injection （18 weeks）Toripalimab （18weeks）CarboplatinDisitamab Vedotin Injection （12 weeks）Sequential EpirubicinSequential CTX

    Invasive breast tumour tissue with low HER2 expression confirmed by the central laboratory, defined as HER2 protein expression of IHC 1+ or IHC …

    Status may be outdated, last updated 2024-03-19Breast Cancer

82. A Study of SHR-A1811 as Neoadjuvant Treatment for Patients With HR-Positive, Low HER2 Expression Breast Cancer

    Recruiting Phase 2 Henan Cancer Hospital Started 2023 NCT05911958

    SHR-A1811 for injection

    HR-positive, HER2 low expression, the expression of Ki-67 exceed 14% invasive breast cancer confirmed by histol…

    HER2 Low Breast Carcinoma

83. Testing the Use of Ado-Trastuzumab Emtansine Compared to the Usual Treatment (Chemotherapy With Docetaxel Plus Trastuzumab) or Trastuzumab Deruxtecan for Recurrent, Metastatic, or Unresectable HER2-Expressing Salivary Gland Cancers

    Recruiting Phase 2 NRG Oncology Started 2023 NCT05408845

    DocetaxelTrastuzumabTrastuzumab Deruxtecan FDA EUTrastuzumab Emtansine

    Pathologically (histologically or cytologically) proven diagnosis of HER2-positive OR HER2-low expressing recurrent/metastatic salivary gland cancer (SGC)

    Metastatic Salivary Gland Carcinoma, Recurrent Salivary Gland Carcinoma, Stage III Major Salivary Gland Cancer AJCC v8, Stage IV Major Salivary Gland Cancer AJCC v8

84. A Phase II Study of Advanced Salivary Gland Carcinoma Based on Molecular Typing

    Active, not recruiting Phase 2 Fudan University Started 2023 NCT05924256

    SHR-A1811SHR 3680 + leuprolideSHR-A1921SHR-A1811

    Arm 4: salivary gland carcinoma patients with low HER-2 expression;

    Advanced Salivary Gland Carcinoma

85. Therapeutic Cancer Vaccine (AST-301, pNGVL3-hICD) in Gastric Cancer

    Active, not recruiting Phase 2 Aston Sci Started 2023 NCT05771584

    AST-301rhuGM-CSF

    HER2 low expression and HER2 overexpression diagnosed according to the 2016 College of American Pa…

    Gastric Cancer

86. Phase 2 Study of Trastuzumab Deruxtecan in the Neoadjuvant Treatment, or Trastuzumab Deruxtecan Plus Capecitabine Plus Durvalumab(MEDI4736) in the Preoperative and Postoperative Adjuvant Treatment for Patients With HER2 Positive Gastric and Gastroesophageal Junction Adenocarcinoma

    Active, not recruiting Phase 2 National Cancer Center Hospital East Started 2022 NCT05034887

    Trastuzumab Deruxtecan (T-DXd) monotherapy FDA EUT-DXd, Durvalumab and Capecitabine Combination

    Has HER2 overexpression (IHC3+, or IHC2+ and ISH positive \[FISH or DISH\]). (HER2 Low expression: IHC1+, or IHC2+ and ISH-negative \[FISH or DISH\] with HER2-ECD \> 11.6 ng/mL…

    Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma

87. Study of AZD9574 as Monotherapy and in Combination With Anti-cancer Agents in Participants With Advanced Solid Malignancies

    Recruiting Phase 1/2 AstraZeneca Started 2022 NCT05417594

    AZD9574Temozolomide (TMZ)[11C]AZ1419 3391Trastuzumab Deruxtecan (T-DXd) FDA EUDatopotamab Deruxtecan (Dato-DXd)

    …atic or recurrent locally advanced unresectable histologically or cytologically confirmed HER2-low or HER2-ultralow breast carcinoma.

    Advanced Solid Malignancies

88. Cinrebafusp Alfa in Combination With Ramucirumab and Paclitaxel in HER2-High Gastric or GEJ Adenocarcinoma and in Combination With Tucatinib in HER2-Low Gastric or GEJ Andenocarinoma

    Active, not recruiting Phase 2 Pieris Pharmaceuticals Started 2021 NCT05190445

    Cinrebafusp alfa (PRS-343) in combination with ramucirumab and paclitaxelCinrebafusp alfa (PRS-343) in combination with tucatinib

    …aclitaxel in HER2-High Gastric or GEJ Adenocarcinoma and in Combination With Tucatinib in HER2-Low Gastric or GEJ Andenocarinoma

    Status may be outdated, last updated 2022-09-08HER2-positive Gastric Cancer

89. Phase II Neoadjuvant Pyrotinib Combined With Neoadjuvant Chemotherapy in HER2-low-expressing and HR Positive Early or Locally Advanced Breast Cancer: a Single-arm, Non-randomized, Single-center, Open Label Trial

    Active, not recruiting Phase 2 Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University Started 2021 NCT05165225

    Pyrotinib + epirubicin and cyclophosphamide followed by docetaxel treatment

    HER2-low-positive (defined here as HER2 IHC 2+ and FISH-) and HR positive(defined here as ER and/o…

    Breast Cancer, HER2-low-expressing Breast Cancer, Hormone Receptor-positive Breast Cancer, Neoadjuvant Therapy

90. Ph1b/2 Study of the Safety and Efficacy of T-DXd Combinations in Advanced HER2-expressing Gastric Cancer (DESTINY-Gastric03)

    Active, not recruiting Phase 2 AstraZeneca Started 2020 NCT04379596

    Fluorouracil (5-FU)CapecitabineDurvalumabOxaliplatinTrastuzumabTrastuzumab deruxtecan FDA EU

    … 3b,4b and Part 5, pathologically documented adenocarcinoma of the stomach/GEJ/esophagus, HER2-low (IHC 2+/ISH-negative or IHC 1+) based on local tissue testing results

    Gastric Cancer

91. Trastuzumab Deruxtecan Alone or in Combination With Anastrozole for the Treatment of Early Stage HER2 Low, Hormone Receptor Positive Breast Cancer

    Recruiting Phase 2 Jonsson Comprehensive Cancer Center Started 2020 NCT04553770

    AnastrozoleTrastuzumab Deruxtecan FDA EU

    Tumor is HER2-low by immunohistochemistry (IHC), defined as 1+ or 2+, confirmed by central testing (central…

    Early-stage Breast Cancer, Hormone Receptor Positive Breast Carcinoma, Invasive Breast Cancer, Stage II Breast Cancer

92. A Study of Novel Anti-cancer Agents in Patients With Metastatic Triple Negative Breast Cancer

    Active, not recruiting Phase 1/2 AstraZeneca Started 2018 NCT03742102

    DurvalumabCapivasertibOleclumabPaclitaxelTrastuzumab deruxtecan FDA EUDatopotamab deruxtecan

    …provide documentation of locally determined advanced/unresectable or metastatic TNBC with HER2 low tumor expression (IHC 2+/ISH-, IHC 1+/ISH-, or IHC 1+/ISH untested)

    Triple Negative Breast Neoplasms

93. Study of [177Lu]Lu-DWJ155 and [68Ga]Ga-DWJ155 in Patients With Solid Tumors

    Recruiting Phase 1 Novartis Started 2026 NCT07660055

    [177Lu]Lu-DWJ155

    Advanced HR+/HER2-low breast cancer with disease progression after prior therapy in the advanced setting

    Breast Cancer, Non-small Cell Lung Cancer (NSCLC), Gastric/Gastroesophageal Junction (GEJ) Cancer, Bladder Cancer

94. A Study of Mutant Selective-Inhibitor (CGT6297), in Patients With Advanced Solid Tumors

    Recruiting Phase 1 Cogent Biosciences Started 2026 NCT07383506

    CGT6297

    Phase 1b Cohort 2, participants must have HR-positive/HER2-negative or HER2-low breast cancer (immunohistochemistry \[IHC\] and in-situ hybridization results must meet A…

    PIK3CA Mutations, Advanced Solid Tumors, Adult, Endometrial Cancer, HR Positive/HER-2 Negative Breast Cancer

95. Testing the Safety of the Combination of Anti-Cancer Drugs CX-5461 (Pidnarulex) and Trastuzumab Deruxtecan (T-DXd) for Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Solid Tumors and Breast Cancer

    Recruiting Phase 1 National Cancer Institute (NCI) Started 2026 NCT07137416

    PidnarulexTrastuzumab Deruxtecan FDA EU

    HR+ HER2 positive/low/ultralow breast cancer or triple negative breast cancer (TNBC) HER2-low breast cancer, with HER2 positive defined by the current American Society of Clinical Onc…

    Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8, Invasive Breast Carcinoma, Locally Advanced Breast Carcinoma

96. A Study of Subcutaneous Trastuzumab Deruxtecan in Participants With Metastatic Solid Tumors

    Recruiting Phase 1 Daiichi Sankyo Started 2025 NCT07015697

    Trastuzumab Deruxtecan FDA EU

    HR-, HER2-low BC: have received a prior systemic cytotoxic therapy in the metastatic setting

    Recurrent or Metastatic Solid Tumors

97. Anlotinib With Trastuzumab Deruxtecan for Previously Treated HER2-Low Advanced Breast Cancer

    Recruiting Phase 1 Fudan University Started 2024 NCT06331169

    AnlotinibTrastuzumab deruxtecan FDA EU

    Has a history of low HER2 expression (IHC 1+\& IHC 2+/ISH- or 0\<IHC\<1+).

    Status may be outdated, last updated 2024-08-30Breast Cancer

98. A Phase 1 of CTX-8371 in Patients With Advanced Malignancies

    Recruiting Phase 1 Compass Therapeutics Started 2024 NCT06150664

    CTX-8371

    Patients with HER2-low tumors (HER2 IHC 1+ or 2+/ISH negative) need to have received fam-trastuzumab deruxtecan …

    Non Small Cell Lung Cancer, Triple Negative Breast Cancer, Hodgkin Lymphoma, Head and Neck Squamous Cell Carcinoma

99. A Study of Valemetostat Tosylate in Combination With DXd ADCs in Subjects With Solid Tumors

    Active, not recruiting Phase 1 Daiichi Sankyo Started 2024 NCT06244485

    Valemetostat tosylateT-DXdDato-DXd

    Has a history of low HER2 expression, defined as immunohistochemistry (IHC) 2+ /in situ hybridization (ISH)-negative or IHC 1+…

    Advanced Solid Tumor

100. First-in-Human Study of OKI-219 in Advanced Solid Tumors and Advanced Breast Cancer

     Active, not recruiting Phase 1 OnKure Started 2024 NCT06239467

     OKI-219FulvestrantTrastuzumabTucatinibAtirmociclibRibociclib

     Participants with HER2-low breast cancer must have received prior trastuzumab deruxtecan.

     Advanced Cancer, Breast Cancer, Advanced Solid Tumors, PI3K Gene Mutation

101. A Clinical Trial of SIBP-A17 Injection in the Treatment of Advanced Solid Tumor Patients.

     Recruiting Phase 1 Shanghai Institute Of Biological Products Started 2024 NCT06512116

     SIBP-A17

     Cohort 1: Late/unresectable and/or metastatic breast cancer with low HER2 expression (IHC1+or IHC2+/FISH -) after standard treatment failure or intolerance.

     Advanced Solid Tumor

102. Evaluate BL-B01D1 in Patients With Metastatic or Unresectable Non-Small Cell Lung Cancer (NSCLC) and Other Solid Tumors

     Recruiting Phase 1 Baili-Bio / SystImmune Started 2023 NCT05983432

     BL-B01D1

     Participants who are HER2 low must have received trastuzumab deruxtecan.

     Non Small Cell Lung Cancer, Esophageal Cancer, Small Cell Lung Cancer, Nasopharyngeal Cancer

103. Phase I Clinical Study of BL-M07D1 in Locally Advanced or Metastatic Digestive Tract Tumors and Other Solid Tumors

     Recruiting Phase 1 Baili-Bio / SystImmune Started 2023 NCT05631964

     BL-M07D1

     Low HER2 expression: IHC 2+ and ISH negative, or IHC 1+.

     Locally Advanced or Metastatic Digestive Tract Tumors, Other Solid Tumors

104. Phase 1 Dose Escalation and Expansion Study of TROP2 CAR Engineered IL15-transduced Cord Blood-derived NK Cells in Patients With Advanced Solid Tumors (TROPIKANA)

     Recruiting Phase 1 M.D. Anderson Cancer Center Started 2023 NCT06066424

     RimiducidTROP2-CAR-NK CellsFludarabine phosphateCyclophosphamide

     …t 2, patients must have histology documented locally advanced or metastatic HER2-negative/HER2-low breast cancer (IHC 0, IHC 1, or IHC 2+/ in situ hybridization negative) breast cancer.

     Solid Tumors

105. IKS014 in Advanced Solid Tumors That Express HER2

     Recruiting Phase 1 Iksuda Therapeutics Started 2023 NCT05872295

     IKS014

     HER2 positive solid tumors with expression defined as IHC3+, IHC2+/ISH+, or low HER2 expression defined as IHC2+ (ISH-) or IHC1+ (ISH- /+ or untested).

     Breast Cancer, Gastric Cancer, Gastroesophageal-junction Cancer

106. A Study of TAVO412 in Patients with Cancer

     Active, not recruiting Phase 1 Tavotek Biotherapeutics Started 2023 NCT05548634

     TAVO412

     Trastuzumab-deruxtecan (HER2-low)

     Status may be outdated, last updated 2024-10-23Cancer

107. Phase 1b Study of EZH1/2 Inhibitor Valemetostat in Combination With Trastuzumab Deruxtecan in Subjects With HER2 Low/Ultra-low/Null Metastatic Breast Cancer

     Active, not recruiting Phase 1 M.D. Anderson Cancer Center Started 2023 NCT05633979

     Trastuzumab deruxtecan FDA EUValemetostat

     Pathologically confirmed HER2 low/ultra-low/null breast cancer.

     Breast Cancer

108. A Phase 1 First-In-Human Study of the Anti-CD73 IPH5301 Alone or in Combination With Chemotherapy and Trastuzumab in Patients With Advanced Solid Tumors

     Active, not recruiting Phase 1 Institut Paoli-Calmettes Started 2022 NCT05143970

     IPH5301 ALONE OR IN COMBINATION WITH CHEMOTHERAPY AND TRASTUZUMAB

     HER2-positive is defined by IHC 3+ or gene amplification by in situ hybridization and HER2-low is defined by IHC 1+ or 2+ and no gene amplification by in situ hybridization.

     Metastatic Cancer, Metastatic Breast Cancer, Metastatic Pancreatic Cancer, Metastatic Gastric Cancer

109. A Study of BL-M07D1 in Patients With Locally Advanced or Metastatic HER2-Positive/Negative Breast Cancer and Other Solid Tumors

     Recruiting Phase 1 Baili-Bio / SystImmune Started 2022 NCT05461768

     BL-M07D1

     HER2 low expression: IHC2+ and ISH negative, or IHC1+;

     Breast Cancer, Locally Advanced or Metastatic Solid Tumor

110. A Phase 1b Study of T-DXd Combinations in HER2-low Advanced or Metastatic Breast Cancer

     Active, not recruiting Phase 1 AstraZeneca Started 2020 NCT04556773

     Trastuzumab deruxtecan FDA EUDurvalumabPaclitaxelCapivasertibAnastrozoleFulvestrant

     Has a history of HER2-low expression, defined as IHC 2+/ISH- or IHC 1+ (ISH- or untested) with a validated assay

     Metastatic Breast Cancer

111. Testing a New Imaging Agent to Identify Cancer

     Active, not recruiting Phase 1 Memorial Sloan Kettering Cancer Center Started 2020 NCT04692831

     89Zr-ss-pertuzumab PET/CT

     Biopsy proven HER2-positive or HER2-low primary malignancy or metastatic disease

     HER-2 Positive Malignant Carcinoma of Breast, HER-2 Protein Overexpression, HER2-positive Metastatic Breast Cancer

112. DS8201a and Pembrolizumab in Participants With Locally Advanced/Metastatic Breast or Non-Small Cell Lung Cancer

     Active, not recruiting Phase 1 Daiichi Sankyo Started 2020 NCT04042701

     Trastuzumab deruxtecan (DS-8201a) FDA EUTrastuzumab deruxtecan (DS-8201a) FDA EUPembrolizumab

     …cally documented, locally advanced/metastatic breast cancer that has centrally determined HER2-low expression (immunohistochemistry \[IHC\] 1+ or IHC 2+/in situ hybridization \[ISH-\])

     Breast Cancer, Non-small Cell Lung Carcinoma

113. First-in-human Study of DS-1062a for Advanced Solid Tumors (TROPION-PanTumor01)

     Active, not recruiting Phase 1 Daiichi Sankyo Started 2018 NCT03401385

     Datopotamab Deruxtecan (Dato-DXd)Steroid Containing Mouthwash

     DS-7300\]. (Note: Participants in the new HR-positive HER2-low breast cancer cohort is required to have prior treatment with T-DXd and must not have bee…

     Hormone Receptor Positive Breast Cancer, Triple Negative Breast Cancer, Non-small Cell Lung Cancer

114. Pilot Study of [68Ga]Ga-ABY-025 Imaging in Patients Undergoing Treatment With HER2-targeted Therapy

     Recruiting Early Phase 1 Vanderbilt-Ingram Cancer Center Started 2026 NCT06828588

     [68Ga]Ga-ABY-025

     …on in at least one lesion (HER2+ solid cancer, or breast cancer patients who are HER2+ or HER2-low) as defined by IHC and FISH studies or with HER2 amplification as defined by a liquid bio…

     Locally Advanced Cancer, Metastatic Cancer, HER2, HER2 + Breast Cancer, HER2 + Gastric Cancer, Squamous Cell Carcinoma of Head and Neck, Esophageal Squamous Cell Carcinoma

115. HEAT Trial (HER2 Antibody Therapy With Lutetium-177)

     Recruiting Early Phase 1 Radiopharm Theranostics Started 2025 NCT06824155

     177Lu-RAD202

     Participants with histologically or cytologically confirmed, HER2 positive or HER2-low, advanced solid tumours that are relapsed/refractory, locally advanced not amenable to cu…

     HER2 Gene Mutation, Advanced Solid Tumors

116. HF50 in HER-2 Positive and Low-expression Advanced Solid Tumors

     Recruiting Early Phase 1 HighField Biopharmaceuticals Started 2025 NCT06822998

     HF50

     Histologically or cytologically confirmed advanced HER-2 positive or HER-2 low-expression solid tumors that are unresectable, metastatic, or have relapsed after standar…

     Advanced Solid Tumors

117. GDF-15 and Its Relationship With Treatment-related ADverse Events in Breast Cancer

     Not yet recruiting No phase Breast Cancer Trials, Australia and New Zealand Started 2026 NCT07465172

     Histologically confirmed diagnosis of metastatic/advanced unresectable HER2-positive or HER2-low breast cancer.

     Breast Cancer

118. A Study of T-DXd in AI-Assessed HER2-Ultralow Metastatic Breast Cancer

     Not yet recruiting No phase Shuangyue Liu Started 2026 NCT07782086

     Trastuzumab Deruxtecan (T-DXd, ENHERTU®) FDA EU

     …cal laboratory using the PATHWAY/VENTANA® HER2 (4B5) assay, and subsequently re-scored as HER2-ultralow (IHC 0

     Breast Cancer

119. A Clinical Study to Explore the Efficacy and Safety of Hyperbaric Oxygen in the Neoadjuvant Treatment of Hormone Receptor Positive Breast Cancer Patients

     Not yet recruiting No phase Guangdong Provincial People's Hospital Started 2025 NCT06825949

     Hormone receptor-positive breast cancer (Luminal/HER2-low (IHC 2+/FISH-negative)).

     Breast Cancers

120. Exploration of the Safety and Efficacy of T-DXd Concurrent With Brain Radiotherapy in Patients With Brain Metastases HER2-positive/HER2-low Advanced Breast Cancer

     Recruiting No phase QIAO LI Started 2025 NCT07117864

     T-DXd concurrent brain radiotherapy

     HER2-positive or HER2-low invasive breast cancer, defined as:

     Breast Cancer

121. PERCIST Evaluation of Trastuzumab Deruxtecan in the Treatment of HER2 Low Breast Cancer

     Not yet recruiting No phase Centre Paul Strauss Started 2025 NCT07130344

     PERCIST Evaluation of Trastuzumab Deruxtecan in the Treatment of HER2 Low Breast Cancer

     Metastatic Breast Cancer, HER 2 Low-expressing Breast Cancer

122. Breast Cancer Implementation Science Study With Educational Intervention

     Recruiting No phase NYU Langone Health Started 2025 NCT06927895

     Confirmed diagnosis of HER2+ or HER2 low breast cancer who are receiving or are about to receive HER2-targeted antibody drug conju…

     Breast Cancer

123. RC48-ADC in HER2-low Advanced Breast Cancer

     Recruiting No phase RenJi Hospital Started 2023 NCT05831878

     Disitamab vedotin

     HER2-low tumors, defined as IHC1+ or IHC2+ with negative FISH test

     Advanced Breast Cancer

124. Phase Ib Study of Axatilimab in Combination With Olaparib in BRCA1/2 and PALB2- Associated Metastatic HER2-negative Breast Cancer

     Recruiting Phase 1 Dana-Farber Cancer Institute Started 2024 NCT06488378

     AxatilimabOlaparib

     …cytologically confirmed metastatic or unresectable HER2 negative breast cancer, including HER2 low (IHC 2+/ISH-, IHC 1+).

     Broad match: HER2-low / ultralow (IHC 1+ or 2+/ISH-)Breast Cancer, PALB2-Mutated Breast Carcinoma, HER2-negative Breast Cancer, BRCA1 Mutation

No trials match these filters.