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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:
    6d
    "Outstanding" ADC Candidates Emerge for SCLC, Other Cancers. (PubMed, Cancer Discov)
    The treatment arsenal for small cell lung cancer could soon include antibody-drug conjugates, with early data from three phase I studies indicating robust response rates to CD56-targeting DXC006, DLL-3-targeting BL-M14D1, and B7-H3-targeting SYS6043. The latter also appears active in other tumor types, including ovarian and breast cancers. As well, phase II findings on a fourth ADC candidate, HER2-targeting trastuzumab brengitecan, suggest its strong efficacy in platinum-resistant ovarian cancer.
    Journal
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    HER-2 (Human epidermal growth factor receptor 2) • DLL3 (Delta Like Canonical Notch Ligand 3) • NCAM1 (Neural cell adhesion molecule 1)
    |
    Herceptin (trastuzumab) • trastuzumab brengitecan (BL-M07D1)
    7d
    A Study of BL-M07D1 Combined With Pertuzumab Versus Docetaxel Plus Trastuzumab and Pertuzumab in Patients With First-line HER2-positive Recurrent or Metastatic Breast Cancer (clinicaltrials.gov)
    P3, N=596, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    Herceptin (trastuzumab) • docetaxel • Perjeta (pertuzumab) • trastuzumab brengitecan (BL-M07D1)
    16d
    A Study of BL-M07D1 Versus Physician's Choice of Chemotherapy in Patients With HER2-expressing Locally Advanced or Metastatic Biliary Tract Cancer After Platinum-containing Chemotherapy Failure (clinicaltrials.gov)
    P3, N=398, Not yet recruiting, Sichuan Baili Pharmaceutical Co., Ltd.
    New P3 trial
    |
    5-fluorouracil • capecitabine • oxaliplatin • trastuzumab brengitecan (BL-M07D1) • levoleucovorin calcium
    29d
    BL-M07D1-205: A Study of BL-M07D1, BL-M07D1+Pertuzumab and BL-M07D1+Pertuzumab+Docetaxel in Patients With Unresectable Locally Advanced or Metastatic HER2-positive Breast Cancer (clinicaltrials.gov)
    P2, N=83, Active, not recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Recruiting --> Active, not recruiting | N=120 --> 83 | Trial completion date: Jun 2026 --> Dec 2026 | Trial primary completion date: Jun 2026 --> Dec 2026
    Enrollment closed • Enrollment change • Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    docetaxel • Perjeta (pertuzumab) • trastuzumab brengitecan (BL-M07D1)
    2ms
    A Study Comparing BL-M07D1 With Physician's Choice of Chemotherapy in Patients With HER2-Expressing Platinum-Resistant Recurrent Epithelial Ovarian Cancer, Fallopian Tube Cancer, and Primary Peritoneal Cancer (clinicaltrials.gov)
    P3, N=404, Not yet recruiting, Sichuan Baili Pharmaceutical Co., Ltd.
    New P3 trial • Platinum resistant
    |
    FOLR1 ( Folate receptor alpha )
    |
    paclitaxel • topotecan • trastuzumab brengitecan (BL-M07D1)
    2ms
    A Study of BL-M07D1 in Patients With a Variety of Solid Tumors Including Locally Advanced or Metastatic HER2-positive/Low-expressing Urinary and Gastrointestinal Tumors (clinicaltrials.gov)
    P1/2, N=42, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Trial completion date: Mar 2026 --> Dec 2026 | Trial primary completion date: Mar 2026 --> Dec 2026
    Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HER-2 expression
    |
    trastuzumab brengitecan (BL-M07D1)
    2ms
    A Study of BL-M07D1 Combined With Pertuzumab Versus Docetaxel Plus Trastuzumab and Pertuzumab in Patients With First-line HER2-positive Recurrent or Metastatic Breast Cancer (clinicaltrials.gov)
    P3, N=596, Not yet recruiting, Sichuan Baili Pharmaceutical Co., Ltd.
    New P3 trial
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    Herceptin (trastuzumab) • docetaxel • Perjeta (pertuzumab) • trastuzumab brengitecan (BL-M07D1)
    3ms
    A Study of BL-M07D1 in Combination With Pembrolizumab in Patients With Unresectable Locally Advanced or Metastatic HER2-Overexpressing Non-Squamous NSCLC (clinicaltrials.gov)
    P2, N=80, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 overexpression
    |
    Keytruda (pembrolizumab) • trastuzumab brengitecan (BL-M07D1)
    4ms
    Open Label Study to Evaluate BL-M07D1 in HER2 Expressing Malignant Solid Tumors (clinicaltrials.gov)
    P1, N=280, Recruiting, SystImmune Inc. | Trial completion date: Aug 2027 --> Apr 2029 | Trial primary completion date: Dec 2025 --> Dec 2028
    Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 amplification • HER-2 mutation • HER-2 expression
    |
    trastuzumab brengitecan (BL-M07D1)
    6ms
    A Study of BL-M07D1 in Combination With Pembrolizumab in Patients With Unresectable Locally Advanced or Metastatic HER2-Overexpressing Non-Squamous NSCLC (clinicaltrials.gov)
    P2, N=80, Not yet recruiting, Sichuan Baili Pharmaceutical Co., Ltd.
    New P2 trial
    |
    Keytruda (pembrolizumab) • trastuzumab brengitecan (BL-M07D1)
    7ms
    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)
    7ms
    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)