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    DRUG:

    izalontamab brengitecan (BL-B01D1)

    i
    Other names: BL-B01D1, Iza-can, BLB01D1, BL B01D1, BMS-986507, iza-bren
    Company:
    BMS, Biokin Pharma
    Drug class:
    Topoisomerase I inhibitor, EGFR-targeted antibody-drug conjugate, HER3-targeted antibody-drug conjugate
    Related drugs:
    17d
    BL-B01D1-204-13: A Study of BL-B01D1+TKI±Pembrolizumab in Patients With Locally Advanced or Metastatic Renal Cancer (clinicaltrials.gov)
    P2, N=260, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | N=120 --> 260
    Enrollment change
    |
    Keytruda (pembrolizumab) • Lenvima (lenvatinib) • Inlyta (axitinib) • izalontamab (SI-B001) • izalontamab brengitecan (BL-B01D1)
    17d
    BL-B01D1-204-11: A Study of BL-B01D1 + Pembrolizumab ± Bevacizumab in Patients With Recurrent or Metastatic Cervical Cancer and Endometrial Cancer (clinicaltrials.gov)
    P2, N=206, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Keytruda (pembrolizumab) • Avastin (bevacizumab) • izalontamab (SI-B001) • izalontamab brengitecan (BL-B01D1)
    17d
    BL-B01D1-305: A Study Comparing BL-B01D1 With Chemotherapy of Physician's Choice in Patients With Recurrent or Metastatic Esophageal Squamous Cell Carcinoma (clinicaltrials.gov)
    P3, N=497, Active, not recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    paclitaxel • docetaxel • irinotecan • izalontamab (SI-B001) • izalontamab brengitecan (BL-B01D1)
    18d
    BL-B01D1-307: A Study Comparing BL-B01D1 With Chemotherapy of Physician's Choice in Patients With Unresectable Locally Advanced or Metastatic Triple-Negative Breast Cancer (clinicaltrials.gov)
    P3, N=418, Active, not recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    gemcitabine • capecitabine • Halaven (eribulin mesylate) • vinorelbine tartrate • izalontamab (SI-B001) • izalontamab brengitecan (BL-B01D1)
    18d
    BL-B01D1-301: A Study Comparing BL-B01D1 With Platinum Based Chemotherapy in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (clinicaltrials.gov)
    P3, N=432, Active, not recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    cisplatin • carboplatin • pemetrexed • izalontamab (SI-B001) • izalontamab brengitecan (BL-B01D1)
    22d
    Study of Izalontamab Brengitecan (BMS-986507) Versus Platinum-Pemetrexed for EGFR-mutated Non-small Cell Lung Cancer After Failure of EGFR TKI Therapy (IZABRIGHT-Lung01) (clinicaltrials.gov)
    P2/3, N=596, Recruiting, Bristol-Myers Squibb | Not yet recruiting --> Recruiting
    Enrollment open
    |
    cisplatin • carboplatin • pemetrexed • izalontamab (SI-B001) • izalontamab brengitecan (BL-B01D1)
    2ms
    Phase 2/3 Trial of Izalontamab Brengitecan vs Platinum-based Chemotherapy for Metastatic Urothelial Cancer With Disease Progression on or After Immunotherapy (clinicaltrials.gov)
    P2/3, N=470, Recruiting, Bristol-Myers Squibb | Not yet recruiting --> Recruiting
    Enrollment open
    |
    cisplatin • carboplatin • gemcitabine • izalontamab (SI-B001) • izalontamab brengitecan (BL-B01D1)
    2ms
    BL-B01D1-303: A Study Comparing BL-B01D1 With Physician's Choice of Chemotherapy in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma (clinicaltrials.gov)
    P3, N=386, Active, not recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Trial completion date: Dec 2027 --> Nov 2026
    Trial completion date
    |
    PD-L1 (Programmed death ligand 1)
    |
    gemcitabine • docetaxel • capecitabine • izalontamab (SI-B001) • izalontamab brengitecan (BL-B01D1)
    2ms
    BL-B01D1-201: A Study of BL-B01D1 in Patients With Multiple Solid Tumors, Including Locally Advanced or Metastatic Urinary System Tumors (clinicaltrials.gov)
    P2, N=76, 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
    |
    izalontamab (SI-B001) • izalontamab brengitecan (BL-B01D1)
    2ms
    A Study of SI-B003, BL-B01D1+SI-B003 and BL-B01D1+PD-1 Monoclonal Antibody in Patients With Locally Advanced or Metastatic Esophageal Cancer, Gastric Cancer, Colorectal Cancer and Other Gastrointestinal Tumors (clinicaltrials.gov)
    P2, N=376, 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 negative
    |
    izalontamab (SI-B001) • izalontamab brengitecan (BL-B01D1) • danvilostomig (SI-B003)
    2ms
    BL-B01D1-303: A Study Comparing BL-B01D1 With Physician's Choice of Chemotherapy in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma (clinicaltrials.gov)
    P3, N=386, Active, not recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Trial completion date: Dec 2025 --> Dec 2027 | Trial primary completion date: Dec 2025 --> Nov 2026
    Trial completion date • Trial primary completion date
    |
    PD-L1 (Programmed death ligand 1)
    |
    gemcitabine • docetaxel • capecitabine • izalontamab (SI-B001) • izalontamab brengitecan (BL-B01D1)
    2ms
    BL-B01D1-SI-B003-201-02: A Study of BL-B01D1, SI-B003 and BL-B01D1+SI-B003 in Patients With Extensive Stage Small Cell Lung Cancer (clinicaltrials.gov)
    P2, N=100, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Trial completion date: Nov 2025 --> Dec 2027 | Trial primary completion date: Nov 2025 --> Dec 2026
    Trial completion date • Trial primary completion date
    |
    izalontamab (SI-B001) • izalontamab brengitecan (BL-B01D1) • danvilostomig (SI-B003)