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    DRUG:

    trastuzumab brengitecan (BL-M07D1)

    i
    Other names: BL-M07D1, T‑Bren, T Bren, TBren, BL M07D1, BLM07D1
    Company:
    Biokin Pharma
    Drug class:
    Topoisomerase I inhibitor, HER2-targeted antibody-drug conjugate
    Related drugs:
    17d
    A Study of BL-M07D1 vs Pembrolizumab-platinum Chemotherapy in First-line Treatment of HER2-mutant Advanced or Metastatic Non-squamous NSCLC (clinicaltrials.gov)
    P3, N=440, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Keytruda (pembrolizumab) • cisplatin • carboplatin • pemetrexed • trastuzumab brengitecan (BL-M07D1)
    17d
    A Study of BL-M07D1 Versus Investigator's Choice of Chemotherapy in Patients With HER2-positive Locally Advanced or Metastatic Gastric or Gastro-esophageal Junction Adenocarcinoma (clinicaltrials.gov)
    P3, N=490, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    trastuzumab brengitecan (BL-M07D1)
    1m
    Open Label Study to Evaluate BL-M07D1 in HER2 Expressing Malignant Solid Tumors (clinicaltrials.gov)
    P1, N=280, Recruiting, SystImmune Inc. | Trial primary completion date: Aug 2025 --> Dec 2025
    Trial primary completion date
    |
    trastuzumab brengitecan (BL-M07D1)
    2ms
    Phase I Clinical Study of BL-M07D1 in Locally Advanced or Metastatic Digestive Tract Tumors and Other Solid Tumors (clinicaltrials.gov)
    P1, N=26, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Trial completion date: Dec 2025 --> Dec 2027 | Trial primary completion date: Dec 2025 --> Dec 2026
    Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HER-2 amplification • HER-2 expression
    |
    trastuzumab brengitecan (BL-M07D1)
    2ms
    A Study of BL-M07D1 in Patients With Locally Advanced or Metastatic HER2 Positive/Low Expression Breast Cancer and Other Solid Tumors (clinicaltrials.gov)
    P1, N=26, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Trial completion date: Dec 2025 --> Dec 2027 | Trial primary completion date: Dec 2025 --> Dec 2026
    Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HER-2 expression • HER-2 underexpression
    |
    trastuzumab brengitecan (BL-M07D1)
    2ms
    A Study of BL-M07D1 in Patients With HER2-expressing Recurrent or Metastatic Gynecologic Malignancies (clinicaltrials.gov)
    P1/2, N=138, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Trial completion date: Dec 2025 --> Dec 2027 | Trial primary completion date: Dec 2025 --> Dec 2026
    Trial completion date • Trial primary completion date
    |
    trastuzumab brengitecan (BL-M07D1)
    3ms
    A Study of BL-M07D1 in Patients With Locally Advanced or Metastatic HER2 Positive/Low Expression Breast Cancer and Other Solid Tumors (clinicaltrials.gov)
    P1, N=26, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Trial primary completion date: Jun 2025 --> Dec 2025
    Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HER-2 expression • HER-2 underexpression
    |
    trastuzumab brengitecan (BL-M07D1)
    3ms
    Phase I Clinical Study of BL-M07D1 in Locally Advanced or Metastatic Digestive Tract Tumors and Other Solid Tumors (clinicaltrials.gov)
    P1, N=26, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Trial primary completion date: Jun 2025 --> Dec 2025
    Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HER-2 amplification • HER-2 expression
    |
    trastuzumab brengitecan (BL-M07D1)
    3ms
    A Study of BL-M07D1 vs Pembrolizumab-platinum Chemotherapy in First-line Treatment of HER2-mutant Advanced or Metastatic Non-squamous NSCLC (clinicaltrials.gov)
    P3, N=440, Not yet recruiting, Sichuan Baili Pharmaceutical Co., Ltd.
    New P3 trial
    |
    Keytruda (pembrolizumab) • cisplatin • carboplatin • pemetrexed • trastuzumab brengitecan (BL-M07D1)
    3ms
    A Study of BL-M07D1 Versus Investigator's Choice of Chemotherapy in Patients With HER2-positive Locally Advanced or Metastatic Gastric or Gastro-esophageal Junction Adenocarcinoma (clinicaltrials.gov)
    P3, N=490, Not yet recruiting, Sichuan Baili Pharmaceutical Co., Ltd.
    New P3 trial
    |
    trastuzumab brengitecan (BL-M07D1)
    4ms
    A Study Comparing BL-M07D1 With T-DM1 in Patients With Unresectable Locally Advanced or Metastatic HER2-positive Breast Cancer (clinicaltrials.gov)
    P3, N=274, Active, not recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    Kadcyla (ado-trastuzumab emtansine) • trastuzumab brengitecan (BL-M07D1)
    4ms
    BL-M07D1-206: A Study of BL-M07D1 Combination Therapy in Patients With Unresectable Locally Advanced or Metastatic HER2-positive Gastric or Gastroesophageal Junction Adenocarcinoma (clinicaltrials.gov)
    P2, N=40, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    trastuzumab brengitecan (BL-M07D1)