marked.bio

HER2 ADC · ADC

trastuzumab rezetecan

23 active trials across 5 of our biomarkers, targeting HER2. Not approved for any biomarker on marked.bio yet.

Also known as SHR-A1811.

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-) 19 24 Phase 3
HER2 (ERBB2) activating mutation 2 2 Phase 3
Claudin 18.2 expression 1 1 Phase 2
EGFR exon 19 deletion / L858R 1 1 Phase 2
MSI-H / dMMR 1 1 Phase 3

Sponsors

Industry sponsors leading active biomarker-selected trials of trastuzumab rezetecan.

  1. Jiangsu Hengrui 4

Trials

23 of 28 trials shown

  1. 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 2026Primary completion 2028-12 NCT07382687

    trastuzumab rezetecan

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

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

  2. A Study of SHR-A1811 in First-line Treatment of Patients With Advanced or Metastatic Non-small Cell Lung Cancer With HER2 Mutations

    Recruiting Phase 3 Jiangsu Hengrui Started 2024Primary completion 2026-02 NCT06430437

    trastuzumab rezetecanpemetrexedpaclitaxelcarboplatincisplatin

    Subjects with central laboratory- confirmed functional HER2 mutations

    HER2 (ERBB2) activating mutationNon-Small Cell Lung Cancer With HER2- Mutations

  3. Injection of SHR-A1811 Versus Physician Choiced Treatment in Patients With Advanced Colorectal Cancer Who Had Failed to Respond to Oxaliplatin, 5-fu, and Irinotecan

    Active, not recruiting Phase 3 Jiangsu Hengrui Started 2024Primary completion 2026-04 NCT06199973

    trastuzumab rezetecantrifluridine/tipiracilregorafenibfruquintinib

    …reatment with oxaliplatin, 5-fluorouracil (such as 5-FU, Capecitabine) , irinotecan (DMMR/MSI-H subjects also need anti-PD-1/PD-L1 antibody treatment failure) ;

    MSI-H / dMMRAdvanced Colorectal Cancer

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

    Active, not recruiting Phase 3 Jiangsu Hengrui Started 2023Primary completion 2026-03 NCT05814354

    trastuzumab rezetecancapecitabineeribulingemcitabinepaclitaxelnab-paclitaxel

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

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

  5. 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 2026Primary completion 2029-03 NCT07699952

    aumolertinibtrastuzumab rezetecan

    Confirmed EGFR mutations via genetic testing, including Exon 19 deletion or L858R point mutation;

    EGFR exon 19 deletion / L858RHER2-low / ultralow (IHC 1+ or 2+/ISH-)Lung Cancer (NSCLC), EGFR Activating Mutation, HER2

  6. A Multicenter, Single-Arm, Prospective Phase II Clinical Study of Trastuzumab Rezetecan Combined With Radiotherapy in Patients With HER2-Mutated Oligoprogressive Advanced Non-Small Cell Lung Cancer

    Not yet recruiting Phase 2 Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Started 2026Primary completion 2029-08 NCT07781202

    trastuzumab rezetecan

    Confirmed HER2 mutation (detected by PCR or NGS).

    HER2 (ERBB2) activating mutationHER2-mutated Advanced Non-small Cell Lung Cancer With Oligoprogression

  7. 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 2026Primary completion 2027-04 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+);

    HER2-low / ultralow (IHC 1+ or 2+/ISH-)Biliary Tract Neoplasms Immunotherapy

  8. 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 2026Primary completion 2030-06 NCT07203729

    trastuzumab rezetecannab-paclitaxeleribulincapecitabinevinorelbinegemcitabine

    Pathologically confirmed HER2-Low unresectable or metastatic breast cancer;

    HER2-low / ultralow (IHC 1+ or 2+/ISH-)HER2-Low Unresectable/Metastatic Breast Cancer Complicated With Visceral Crisis

  9. 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 2026Primary completion 2028-02 NCT07383818

    trastuzumab rezetecantoripalimabNeoadjuvant Chemotherapy

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

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

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

    Not yet recruiting Phase 2 Tang-Du Hospital Started 2026Primary completion 2028-06 NCT07618923

    Dalpiciclib 125mgAromatase Inhibitortrastuzumab rezetecan

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

    HER2-low / ultralow (IHC 1+ or 2+/ISH-)Breast Cancer, HR Positive/HER2 Low Breast Cancer

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

    Recruiting Phase 2 Jiangsu Hengrui Started 2026Primary completion 2028-06 NCT07497386

    trastuzumab rezetecantrastuzumab deruxtecan FDA EU

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

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

  12. 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 2026Primary completion 2027-04 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+)

    HER2-low / ultralow (IHC 1+ or 2+/ISH-)Biliary Tract Neoplasms Immunotherapy

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

    Recruiting Phase 2 Tianjin Medical University Cancer Institute and Hospital Started 2026Primary completion 2028-09 NCT07817082

    trastuzumab rezetecan

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

    HER2-low / ultralow (IHC 1+ or 2+/ISH-)Advanced Breast Cancer With Ultra-Low HER2 Expression

  14. 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 2026Primary completion 2028-10 NCT07317778

    trastuzumab rezetecanadebrelimabTaxane Chemotherapycyclophosphamide

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

    HER2-low / ultralow (IHC 1+ or 2+/ISH-)Breast Cancer Early Stage Breast Cancer (Stage 1-3), HR Positive/HER2 Low Breast Cancer

  15. 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 2025Primary completion 2028-06 NCT07037199

    trastuzumab rezetecan

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

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

  16. 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 2025Primary completion 2027-03 NCT07305246

    trastuzumab rezetecanletrozoleTAC/AC-T

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

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

  17. 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 2025Primary completion 2027-12 NCT07047443

    trastuzumab rezetecan

    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…

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

  18. 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 2025Primary completion 2027-06 NCT06975462

    trastuzumab rezetecan

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

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

  19. 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

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

    Recruiting Phase 2 Shengjing Hospital Started 2024Primary completion 2026-02 NCT06340230

    trastuzumab rezetecanadebrelimab

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

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

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

    Recruiting Phase 2 Henan Cancer Hospital Started 2023Primary completion 2028-12 NCT05769010

    trastuzumab rezetecanpyrotinibbevacizumabAdebelizumab

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

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

  22. 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 2023Primary completion 2024-12 NCT05911958

    trastuzumab rezetecan

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

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

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

    Active, not recruiting Phase 2 Fudan University Started 2023Primary completion 2026-12 NCT05924256

    trastuzumab rezetecanSHR 3680 + leuprolideSHR-A1921

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

    HER2-low / ultralow (IHC 1+ or 2+/ISH-)Advanced Salivary Gland Carcinoma