marked.bio

HER2 ADC · ADC

BL-M07D1

5 active trials across 2 of our biomarkers, targeting HER2. Not approved for any biomarker on marked.bio yet.

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-) 4 4 Phase 3
HER2 (ERBB2) activating mutation 1 1 Phase 3

Sponsors

Industry sponsors leading active biomarker-selected trials of BL-M07D1.

  1. Baili-Bio / SystImmune 5

Trials

5 of 5 trials shown

  1. A Study of BL-M07D1 vs Pembrolizumab-platinum Chemotherapy in First-line Treatment of HER2-mutant Advanced or Metastatic Non-squamous NSCLC

    Recruiting Phase 3 Baili-Bio / SystImmune Started 2025Primary completion 2027-12 NCT07178795

    BL-M07D1pembrolizumabpemetrexedcarboplatincisplatin

    A Study of BL-M07D1 vs Pembrolizumab-platinum Chemotherapy in First-line Treatment of HER2-mutant Advanced or Metastatic Non-squamous NSCLC

    HER2 (ERBB2) activating mutationNon-squamous Non-small Cell Lung Cancer

  2. 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 2025Primary completion 2027-05 NCT06957886

    BL-M07D1capecitabineeribulingemcitabinepaclitaxel

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

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

  3. 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 2026Primary completion 2028-12 NCT07678957

    BL-M07D1trastuzumab deruxtecan FDA EU

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

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

  4. 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 2023Primary completion 2026-12 NCT05631964

    BL-M07D1

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

    HER2-low / ultralow (IHC 1+ or 2+/ISH-)Locally Advanced or Metastatic Digestive Tract Tumors, Other Solid Tumors

  5. 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 2022Primary completion 2026-12 NCT05461768

    BL-M07D1

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

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