marked.bio

HER2 ADC · ADC

disitamab vedotin

12 active trials across 4 of our biomarkers, targeting HER2. Not approved for any biomarker on marked.bio yet.

Also known as RC48, Aidixi.

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 17 Phase 3
HER2 (ERBB2) activating mutation 2 4 Phase 1/2
BRCA1/2 mutation 1 2 Phase 1/2
EGFR exon 19 deletion / L858R 0 2 –

Sponsors

Industry sponsors leading active biomarker-selected trials of disitamab vedotin.

  1. RemeGen 5
  2. Pfizer 2

Trials

12 of 22 trials shown

  1. 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 2025Primary completion 2028-05 NCT06944496

    disitamab vedotintislelizumaboxaliplatincapecitabine

    HER2-low expression

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

  2. 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 2023Primary completion 2028-03 NCT05904964

    disitamab vedotin

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

    HER2-low / ultralow (IHC 1+ or 2+/ISH-)Status may be outdated, last updated 2023-06-22HR Positive/HER2 Low Expression Metastatic Breast Cancer

  3. A Study of RC48-ADC Combined With Pyrotinib For Treatment of Local Advanced or Metastasis NSCLC With HER2 Mutation

    Not yet recruiting Phase 1/2 RemeGen Starts 2027Primary completion 2027-12 NCT05745740

    disitamab vedotinpyrotinib

    Documented HER2 exon 20 insertion mutation.

    HER2 (ERBB2) activating mutationNon-small Cell Lung Cancer

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

    Active, not recruiting Phase 1/2 Pfizer Started 2025Primary completion 2027-10 NCT06966453

    disitamab vedotin

    Known germline BRCA mutation must have received a PARP-inhibitor if available as local standard of care therapy and no…

    BRCA1/2 mutationHER2-low / ultralow (IHC 1+ or 2+/ISH-)Breast Cancer, Breast Neoplasms

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

    Recruiting Phase 2 RemeGen Started 2025Primary completion 2026-10 NCT06642545

    disitamab vedotinRC148Albumin-bound Paclitaxonetoripalimab

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

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

  6. Neoadjuvant Envafolimab Plus Disitamab Vedotin and Carboplatin in Resectable HER2-Mutant Non-Small-Cell Lung Cancer

    Recruiting Phase 2 Guangdong Provincial People's Hospital Started 2024Primary completion 2027-06 NCT06734182

    disitamab vedotincarboplatin

    HER2 mutations identified by histological specimens;

    HER2 (ERBB2) activating mutationNon-small Cell Lung Cancer

  7. 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 2024Primary completion 2026-12 NCT07446452

    disitamab vedotinbevacizumab

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

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

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

    Active, not recruiting Phase 2 Pfizer Started 2024Primary completion 2029-07 NCT06157892

    disitamab vedotintucatinib

    Cohort A (HER2-Low Breast Cancer) Inclusion Criteria

    HER2-low / ultralow (IHC 1+ or 2+/ISH-)Breast Neoplasms, Gastroesophageal Junction Adenocarcinoma, HER2 Low Breast Neoplasms, HER2 Positive Breast Neoplasms

  9. 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

  10. 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 2024Primary completion 2025-06 NCT06389006

    disitamab vedotintoripalimabEpirubicincyclophosphamide

    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…

    HER2-low / ultralow (IHC 1+ or 2+/ISH-)Status may be outdated, last updated 2024-05-23Breast Cancer

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

    Recruiting Phase 2 RemeGen Started 2023Primary completion 2025-12 NCT06227117

    disitamab vedotintoripalimabcarboplatinSequential Epirubicincyclophosphamide

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

    HER2-low / ultralow (IHC 1+ or 2+/ISH-)Status may be outdated, last updated 2024-03-19Breast Cancer

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

    Recruiting No phase RenJi Hospital Started 2023Primary completion 2026-12 NCT05831878

    disitamab vedotin

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

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