marked.bio

anti-HER2 antibody · antibody

trastuzumab

23 active trials across 15 of our biomarkers, targeting HER2. Not approved for any biomarker on marked.bio yet.

Also known as Herceptin.

Counts only trials that select patients by one of the biomarkers on marked.bio, not every trial of this drug.

Biomarkers

BiomarkerActive trialsAll trialsFurthest active phase
HER2-low / ultralow (IHC 1+ or 2+/ISH-) 10 14 Phase 2/3
MSI-H / dMMR 4 5 Phase 3
PIK3CA activating mutation 4 11 Phase 3
HER2 (ERBB2) activating mutation 3 7 Phase 2
BRCA1/2 mutation 1 3 Phase 2
Claudin 18.2 expression 1 1 Phase 2
EGFR exon 19 deletion / L858R 1 2 Phase 1/2
KRAS G12C 1 3 Phase 1
KRAS G12D 1 2 Phase 1
ALK fusion 0 4 –
BRAF V600E 0 4 –
FGFR2 fusion or rearrangement 0 1 –
FGFR3 alteration (mutation or fusion) 0 1 –
MET exon 14 skipping 0 1 –
RET fusion or mutation 0 1 –

Sponsors

Industry sponsors leading active biomarker-selected trials of trastuzumab.

  1. BridgeBio Oncology Therapeutics 1
  2. Novartis 1
  3. Roche 1
  4. Pfizer 1
  5. SUNHO Biopharmaceutical 1
  6. Daiichi Sankyo 1
  7. BioNTech 1
  8. AstraZeneca 1
  9. OnKure 1
  10. Teligene 1

Trials

23 of 48 trials shown

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

    Recruiting Phase 2/3 SUNHO Biopharmaceutical Started 2024Primary completion 2028-07 NCT06504732

    IAH0968trastuzumab

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

    HER2-low / ultralow (IHC 1+ or 2+/ISH-)Stomach Neoplasms, Solid Tumor

  2. 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 2023Primary completion 2027-10 NCT05950945

    trastuzumab deruxtecan FDA EUtrastuzumab

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

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

  3. Study of Alpelisib (BYL719) in Combination With Trastuzumab and Pertuzumab as Maintenance Therapy in Patients With HER2-positive Advanced Breast Cancer With a PIK3CA Mutation

    Active, not recruiting Phase 3 Novartis Started 2020Primary completion 2027-02 NCT04208178

    alpelisib FDA EUtrastuzumabpertuzumab

    Applies only to Part 2: Participant has a PIK3CA mutation(s) present in tumor prior to enrollment, locally confirmed per test listed in protocol or…

    PIK3CA activating mutationAdvanced HER2+Breast Cancer

  4. Identification and Treatment Of Micrometastatic Disease in Stage III Colon Cancer

    Active, not recruiting Phase 3 Massachusetts General Hospital Started 2020Primary completion 2026-12 NCT03803553

    FOLFIRIleucovorinfluorouracilirinotecannivolumab FDA EUencorafenibbinimetinibcetuximabtrastuzumabpertuzumab

    Presence of deficient (d) DNA mismatch repair (dMMR) may be assessed by IHC for MMR protein expression (MLH1, MSH2, MSH6, PMS2) where loss of…

    MSI-H / dMMRMetastatic Colon Cancer, Stage III Colon Cancer

  5. Neoadjuvant SHR-A1811 and SHR-A1701 ± Pertuzumab for Potentially Immunotherapy-Sensitive GC or GEJ Adenocarcinoma

    Not yet recruiting Phase 2 The First Affiliated Hospital with Nanjing Medical University Started 2026Primary completion 2027-08 NCT07716111

    trastuzumabpertuzumab

    Biomarker Status: PD-L1 CPS ≥1, EBV-positive, or dMMR/MSI-H

    MSI-H / dMMRGastric or Gastroesophageal Junction Adenocarcinoma

  6. A Phase II, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of Neoadjuvant Therapy With Inavolisib Plus Pertuzumab and Trastuzumab as Subcutaneous (PH-FDC SC) and 3-week Cycle Nab-paclitaxel for PIK3CA-mutated, HER2+, eBC

    Not yet recruiting Phase 2 Zhimin Shao Started 2025Primary completion 2026-12 NCT07245797

    pertuzumabtrastuzumabnab-paclitaxelinavolisib FDA EU

    HER2+ disease with confirmed ER-status, PR-status, HER2-status, PIK3CA mutation (tumor), Ki-67 value on core biopsy (target lesion).

    PIK3CA activating mutationBreast Cancer

  7. 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 2025Primary completion 2029-08 NCT06827236

    DB-1303trastuzumabpumitamig

    …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…

    HER2-low / ultralow (IHC 1+ or 2+/ISH-)Locally Advanced Breast Cancer, Unresectable Breast Carcinoma, Metastatic Breast Cancer

  8. 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 2025Primary completion 2028-08 NCT06680596

    trastuzumab

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

    HER2-low / ultralow (IHC 1+ or 2+/ISH-)Breast Cancer Metastatic, Breast Cancer Stage IV

  9. 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 2025Primary completion 2028-06 NCT07198724

    elacestranttrastuzumab deruxtecan FDA EUtrastuzumab

    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…

    HER2-low / ultralow (IHC 1+ or 2+/ISH-)Metastatic Breast Cancer, HER2 Low Breast Carcinoma, HER2-negative Breast Cancer, Breast Cancer

  10. Establishment of Precision Targeted Therapy Strategies for Advanced Gastric Cancer Based on Novel Molecular Subtyping

    Not yet recruiting Phase 2 China Medical University Started 2025Primary completion 2029-08 NCT06881017

    trastuzumabadebrelimabapatinibS-1capecitabineoxaliplatinzolbetuximab FDA EUtrastuzumab rezetecanSHR-A1904SHR-1701

    Archival or fresh tumor tissue sample available for biomarker testing (HER2, CLDN18.2, and PD-L1 expression);

    Claudin 18.2 expressionGastric Cancer, HER2 + Gastric Cancer, CLDN18.2-positive Adenocarcinoma of the Gastroesophageal Junction, PD-L1 Positive

  11. TL938 and Trastuzumab for Patients With HER2-positive Metastatic Colorectal Cancer

    Recruiting Phase 2 Teligene Started 2025Primary completion 2026-10 NCT06589830

    TL938 Capsulestrastuzumab

    …ere deficient in mismatch repair (dMMR) proteins or were microsatellite instability-high (MSI-H) must also have received an ant-programmed cell death protain-1 mAb;

    MSI-H / dMMRColorectal Cancer Metastatic, Advanced Colorectal Cancer

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

    Recruiting Phase 1/2 Zhejiang Cancer Hospital Started 2024Primary completion 2026-08 NCT06650332

    cadonilimabtrastuzumabXELOXdisitamab vedotinmFOLFOX6

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

    HER2-low / ultralow (IHC 1+ or 2+/ISH-)Status may be outdated, last updated 2024-10-21Metastatic HER2 Positive Gastroesophageal Junction Cancer

  13. Genomics Guided Targeted Post-neoadjuvant Therapy in Patients With Early Breast Cancer (COGNITION-GUIDE)

    Recruiting Phase 2 German Cancer Research Center Started 2023Primary completion 2030-03 NCT05332561

    atezolizumabinavolisibipatasertibolaparibsacituzumab govitecantrastuzumabpertuzumab

    Arm 6 (Trastuzumab / Pertuzumab, ERBBB): HER2 exon-20 insertion, Activating HER2-mutation

    HER2 (ERBB2) activating mutationBRCA1/2 mutationEarly-stage Breast Cancer

  14. 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 2023Primary completion 2028-07 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)

    HER2-low / ultralow (IHC 1+ or 2+/ISH-)Metastatic Salivary Gland Carcinoma, Recurrent Salivary Gland Carcinoma, Stage III Major Salivary Gland Cancer AJCC v8, Stage IV Major Salivary Gland Cancer AJCC v8

  15. Necitumumab and Trastuzumab in Combination With Osimertinib for the Treatment of Refractory Epidermal Growth Factor Receptor (EGFR)-Mutated Stage IV Non-small Cell Lung Cancer

    Active, not recruiting Phase 1/2 Jonsson Comprehensive Cancer Center Started 2021Primary completion 2026-12 NCT04285671

    necitumumabosimertinib FDA EUtrastuzumab

    Enrollment of patients with mutations other than exon 19 deletion and the L858R point mutation require literature supporting sensitivity to EGFR tyrosine k…

    EGFR exon 19 deletion / L858RMetastatic Lung Non-Small Cell Carcinoma, Refractory Lung Non-Small Cell Carcinoma, Stage IV Lung Cancer American Joint Committee on Cancer (AJCC) v8, Stage IVA Lung Cancer AJCC v8

  16. Basket Study of Tucatinib and Trastuzumab in Solid Tumors With HER2 Alterations

    Active, not recruiting Phase 2 Pfizer Started 2021Primary completion 2023-11 NCT04579380

    tucatinibtrastuzumabfulvestrant

    Known activating HER2 mutations detected in fresh or archival tumor tissue or blood

    HER2 (ERBB2) activating mutationUterine Neoplasms, Uterine Cervical Neoplasms, Biliary Tract Neoplasms, Urologic Neoplasms

  17. Post-op T-DM1 in HER-2+ Salivary Gland Carcinomas

    Recruiting Phase 2 Dana-Farber Cancer Institute Started 2020Primary completion 2028-02 NCT04620187

    trastuzumabtrastuzumab emtansine

    HER2 or ERBB2 mutated on tumor genomic sequencing assay (see Section 9.1 for permitted HER2 mutations)

    HER2 (ERBB2) activating mutationSalivary Gland Cancer, HER2 Gene Mutation

  18. 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 2020Primary completion 2027-05 NCT04379596

    fluorouracilcapecitabinedurvalumaboxaliplatintrastuzumabtrastuzumab deruxtecan FDA EUcisplatinpembrolizumabVolrustomigRilvegostomig

    … 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

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

  19. Neoadjuvant SHR-A1811 and SHR-A1701 for Potentially Immunotherapy-Sensitive GC or GEJ Adenocarcinoma

    Not yet recruiting Phase 1 The First Affiliated Hospital with Nanjing Medical University Started 2026Primary completion 2027-05 NCT07581574

    trastuzumab

    Biomarker Status: PD-L1 CPS ≥1, EBV-positive, or dMMR/MSI-H

    MSI-H / dMMRGastric or Gastroesophageal Junction Adenocarcinoma

  20. Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors

    Recruiting Phase 1 BridgeBio Oncology Therapeutics Started 2024Primary completion 2028-11 NCT06625775

    BBO-10203trastuzumabfulvestrantribociclibFOLFOXbevacizumab

    …-positive advanced breast cancer (aBC), HR-positive/HER2-negative advanced breast cancer, KRAS mutant advanced colorectal cancer (aCRC), or KRAS mutant advanced non-small cell lung cancer (aN…

    KRAS G12CKRAS G12DPIK3CA activating mutationSolid Tumor, Adult, Metastatic Breast Cancer, Advanced Breast Cancer, HER2 Mutation-Related Tumors

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

    Active, not recruiting Phase 1 OnKure Started 2024Primary completion 2026-12 NCT06239467

    OKI-219fulvestranttrastuzumabtucatinibAtirmociclibribociclib

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

    HER2-low / ultralow (IHC 1+ or 2+/ISH-)Advanced Cancer, Breast Cancer, Advanced Solid Tumors, PI3K Gene Mutation

  22. 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 2022Primary completion 2027-03 NCT05143970

    trastuzumab

    HER2-low breast cancer patients must be candidate to paclitaxel-based chemotherapy according to st…

    HER2-low / ultralow (IHC 1+ or 2+/ISH-)Metastatic Cancer, Metastatic Breast Cancer, Metastatic Pancreatic Cancer, Metastatic Gastric Cancer

  23. To Evaluate the Safety, Tolerability, and Pharmacokinetics of Inavolisib Single Agent in Participants With Solid Tumors and in Combination With Endocrine and Targeted Therapies in Participants With Breast Cancer

    Active, not recruiting Phase 1 Roche Started 2016Primary completion 2026-12 NCT03006172

    inavolisib FDA EUfulvestrant FDA EUletrozolepalbociclib FDA EUmetformintrastuzumabpertuzumab

    Locally advanced, recurrent, or metastatic, PIK3CA mutant, incurable solid tumor malignancy, including breast cancer

    PIK3CA activating mutationBreast Cancer, Solid Tumor