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    DRUG:

    BL-M07D1

    i
    Other names: BL-M07D1
    Company:
    Biokin Pharma
    Drug class:
    Topoisomerase I inhibitor, HER2-targeted antibody-drug conjugate
    Related drugs:
    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. | N=58 --> 138
    Enrollment change • Metastases
    |
    BL-M07D1
    2ms
    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=46, Not yet recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | N=120 --> 46 | Trial completion date: Jun 2026 --> Oct 2026 | Initiation date: Jul 2024 --> Oct 2024 | Trial primary completion date: Jun 2026 --> Oct 2026
    Enrollment change • Trial completion date • Trial initiation date • Trial primary completion date • Combination therapy • Metastases
    |
    capecitabine • 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: Aug 2024 --> Dec 2024 | Trial primary completion date: Aug 2024 --> Dec 2024
    Trial completion date • Trial primary completion date • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HER-2 expression • HER-2 underexpression
    |
    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=120, Not yet recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | N=86 --> 120
    Enrollment change • Combination therapy • Metastases
    |
    capecitabine • BL-M07D1
    5ms
    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=120, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    |
    docetaxel • Perjeta (pertuzumab) • BL-M07D1
    6ms
    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=120, Not yet recruiting, Sichuan Baili Pharmaceutical Co., Ltd.
    New P2 trial • Metastases
    |
    docetaxel • Perjeta (pertuzumab) • BL-M07D1
    6ms
    A Study Comparing BL-M07D1 With T-DM1 in Patients With Unresectable Locally Advanced or Metastatic HER2-positive Breast Cancer (clinicaltrials.gov)
    P3, N=268, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Kadcyla (ado-trastuzumab emtansine) • BL-M07D1
    6ms
    A Study of BL-M07D1+PD-1 Monoclonal Antibody and BL-M07D1+PD-1 Monoclonal Antibody+Capecitabine in Patients With Locally Advanced or Metastatic HER2-positive Gastric or Gastroesophageal Junction Adenocarcinoma (clinicaltrials.gov)
    P2, N=86, Not yet recruiting, Sichuan Baili Pharmaceutical Co., Ltd.
    New P2 trial
    |
    capecitabine • BL-M07D1
    6ms
    A Study of BL-M07D1 in Patients With HER2-mutated, Locally Advanced or Metastatic Non-small-cell Lung Cancer (clinicaltrials.gov)
    P1/2, N=58, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 mutation
    |
    BL-M07D1
    8ms
    A Study of BL-M07D1 in Patients With HER2-expressing Recurrent or Metastatic Gynecologic Malignancies (clinicaltrials.gov)
    P1/2, N=58, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    BL-M07D1
    8ms
    A Study Comparing BL-M07D1 With T-DM1 in Patients With Unresectable Locally Advanced or Metastatic HER2-positive Breast Cancer (clinicaltrials.gov)
    P3, N=268, Not yet recruiting, Sichuan Baili Pharmaceutical Co., Ltd.
    New P3 trial • Metastases
    |
    Kadcyla (ado-trastuzumab emtansine) • BL-M07D1
    8ms
    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. | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HER-2 expression • HER-2 underexpression
    |
    BL-M07D1
    9ms
    Open Label Study to Evaluate BL-M07D1 in HER2 Expressing Malignant Solid Tumors (clinicaltrials.gov)
    P1, N=280, Recruiting, SystImmune Inc.
    New P1 trial • Metastases
    |
    BL-M07D1
    9ms
    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, Not yet recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Trial completion date: Nov 2025 --> Mar 2026 | Initiation date: Nov 2023 --> Mar 2024 | Trial primary completion date: Nov 2025 --> Mar 2026
    Trial completion date • Trial initiation date • Trial primary completion date • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HER-2 expression • HER-2 underexpression
    |
    BL-M07D1
    9ms
    A Study of BL-M07D1 in Patients With HER2-mutated, Locally Advanced or Metastatic Non-small-cell Lung Cancer (clinicaltrials.gov)
    P1/2, N=58, Not yet recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Trial completion date: Dec 2025 --> Mar 2026 | Initiation date: Dec 2023 --> Mar 2024 | Trial primary completion date: Dec 2025 --> Mar 2026
    Trial completion date • Trial initiation date • Trial primary completion date • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 mutation
    |
    BL-M07D1
    11ms
    A Study of BL-M07D1 in Patients With HER2-expressing Recurrent or Metastatic Gynecologic Malignancies (clinicaltrials.gov)
    P1/2, N=58, Not yet recruiting, Sichuan Baili Pharmaceutical Co., Ltd.
    Trial completion date • Trial initiation date • Trial primary completion date • Metastases
    |
    BL-M07D1
    1year
    A Study of BL-M07D1 in Patients With HER2-expressing Recurrent or Metastatic Gynecologic Malignancies (clinicaltrials.gov)
    P1/2, N=58, Not yet recruiting, Sichuan Baili Pharmaceutical Co., Ltd.
    New P1/2 trial • Metastases
    |
    BL-M07D1
    1year
    BL-M07D1, an antibody-drug conjugate directed to HER2 in patients with locally advanced or metastatic Breast Cancer with HER2-positive/low-expression and other solid tumors: Results from a first-in-human phase 1 study (SABCS 2023)
    BL-M07D1 demonstrated encouraging efficacy in heavily pretreated HER2 expressing cancers, especially in HER2+ BC. The safety profile showed adequate safety and tolerability. Clinical trial identification: NCT05461768.
    Clinical • P1 data • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HER-2 expression
    |
    BL-M07D1
    1year
    A Study of BL-M07D1 in Patients With HER2-mutated, Locally Advanced or Metastatic Non-small-cell Lung Cancer (clinicaltrials.gov)
    P1/2, N=58, Not yet recruiting, Sichuan Baili Pharmaceutical Co., Ltd.
    New P1/2 trial • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 mutation
    |
    BL-M07D1
    1year
    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, Not yet recruiting, Sichuan Baili Pharmaceutical Co., Ltd.
    New P1/2 trial • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HER-2 expression • HER-2 underexpression
    |
    BL-M07D1
    over1year
    BL-M07D1, a novel HER2-targeting ADC, demonstrates potent anti-tumor efficacy in preclinical pharmacodynamic models (AACR 2023)
    In this model, BL-M07D1 exhibited stronger tumor inhibition than T-DM1, consistent with bystander effects that are also exhibited by DS-8201.In conclusion, in vivo studies suggest that BL-M07D1, a novel HER2-targeting ADC, is potentially more efficacious in a broader patient population than T-DM1, and mediate superior anti-tumor efficacy than DS-8201. The clinical phase I is under way and the available data exhibit excellent efficacy in breast cancer therapy with acceptable tolerability.
    PK/PD data • Preclinical
    |
    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HER-2 negative • HER-2 expression • EGFR H1975
    |
    Kadcyla (ado-trastuzumab emtansine) • Enhertu (fam-trastuzumab deruxtecan-nxki) • BL-M07D1
    almost2years
    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. | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HER-2 amplification • HER-2 expression
    |
    BL-M07D1
    almost2years
    Phase I Clinical Study of BL-M07D1 in Locally Advanced or Metastatic Digestive Tract Tumors and Other Solid Tumors (clinicaltrials.gov)
    P1, N=26, Not yet recruiting, Sichuan Baili Pharmaceutical Co., Ltd.
    New P1 trial • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HER-2 amplification • HER-2 expression
    |
    BL-M07D1
    almost2years
    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. | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HER-2 expression • HER-2 underexpression
    |
    BL-M07D1
    over2years
    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.
    New P1 trial
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HER-2 expression • HER-2 underexpression
    |
    BL-M07D1