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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:
    4d
    A Study Comparing BL-B01D1 With Chemotherapy of Physician's Choice in Patients With Unresectable Locally Advanced, Recurrent, or Metastatic HR+/HER2- Breast Cancer After Failure of Prior Endocrine Therapy(PANKU-Breast03) (clinicaltrials.gov)
    P3, N=446, Not yet recruiting, Sichuan Baili Pharmaceutical Co., Ltd.
    New P3 trial
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative
    |
    capecitabine • albumin-bound paclitaxel • izalontamab brengitecan (BL-B01D1)
    8d
    A Study Comparing BL-B01D1 in Combination With Osimertinib Versus Osimertinib Alone in Patients With Locally Advanced, Unresectable EGFR-mutated Non-small Cell Lung Cancer(Stage III) Whose Disease Has Not Progressed Following Definitive Platinum-based Chemoradiation Therapy(PANKU-Lung08) (clinicaltrials.gov)
    P3, N=418, Not yet recruiting, Sichuan Baili Pharmaceutical Co., Ltd.
    New P3 trial
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation
    |
    Tagrisso (osimertinib) • izalontamab brengitecan (BL-B01D1)
    8d
    A Study of BL-B01D1 in Combination With Osimertinib as Perioperative Therapy in Patients With EGFR-mutated Resectable Non-small Cell Lung Cancer(PANKU-Lung09) (clinicaltrials.gov)
    P2/3, N=90, Not yet recruiting, Sichuan Baili Pharmaceutical Co., Ltd.
    New P2/3 trial
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation
    |
    cisplatin • Tagrisso (osimertinib) • carboplatin • pemetrexed • izalontamab brengitecan (BL-B01D1)
    8d
    A Study of BL-B01D1 Combination Therapy in Patients With Metastatic Castration-resistant Prostate Cancer (clinicaltrials.gov)
    P2/3, N=180, Not yet recruiting, Sichuan Baili Pharmaceutical Co., Ltd.
    New P2/3 trial
    |
    Lynparza (olaparib) • abiraterone acetate • izalontamab brengitecan (BL-B01D1)
    9d
    BL-B01D1-210: A Study of BL-B01D1 Monotherapy, BL-B01D1 in Combination With Lenvatinib, BL-B01D1 in Combination With PD-1 Monoclonal Antibody, and BL-B01D1 in Combination With PD-1 Monoclonal Antibody and Bevacizumab in Patients With Advanced Hepatocellular Carcinoma (clinicaltrials.gov)
    P2, N=74, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | N=46 --> 74
    Enrollment change
    |
    Avastin (bevacizumab) • Lenvima (lenvatinib) • izalontamab brengitecan (BL-B01D1) • Anyouping (finotonlimab)
    23d
    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=500, Recruiting, Bristol-Myers Squibb | Trial completion date: May 2031 --> Nov 2030 | Trial primary completion date: Sep 2028 --> Dec 2028
    Trial completion date • Trial primary completion date
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion
    |
    cisplatin • carboplatin • pemetrexed • izalontamab (SI-B001) • izalontamab brengitecan (BL-B01D1)
    1m
    A Study Comparing BL-B01D1 With Treatment of Physician's Choice in Patients With Locally Advanced or Metastatic Biliary Tract Cancer After Failure of Platinum-based Chemotherapy and PD-1/PD-L1 Monoclonal Antibody Therapy(PANKU-BTC01) (clinicaltrials.gov)
    P3, N=538, Not yet recruiting, Sichuan Baili Pharmaceutical Co., Ltd.
    New P3 trial
    |
    5-fluorouracil • capecitabine • oxaliplatin • izalontamab brengitecan (BL-B01D1) • levoleucovorin calcium
    2ms
    A Study of BL-B01D1 in Combination With Tislelizumab ±5-Fluorouracil Versus Platinum-Based Chemotherapy Plus Tislelizumab as First-line Treatment in Patients With Unresectable, Locally Advanced Recurrent or Metastatic Esophageal Squamous Cell Carcinoma(PANKU-Esophagus02) (clinicaltrials.gov)
    P2/3, N=90, Not yet recruiting, Sichuan Baili Pharmaceutical Co., Ltd.
    New P2/3 trial
    |
    cisplatin • paclitaxel • 5-fluorouracil • Tevimbra (tislelizumab-jsgr) • izalontamab brengitecan (BL-B01D1)
    2ms
    CA2440012: Phase 2/3 Trial of Izalontamab Brengitecan vs Platinum-based Chemotherapy for Metastatic Urothelial Cancer with Disease Progression on or After Immunotherapy (2025-522400-24-00)
    P2/3, N=207, Recruiting, Bristol-Myers Squibb Services Unlimited Company
    New P2/3 trial
    |
    cisplatin • carboplatin • gemcitabine • Neulasta (pegfilgrastim) • izalontamab (SI-B001) • izalontamab brengitecan (BL-B01D1)
    2ms
    BL-B01D1-310: A Study Comparing BL-B01D1 With the Investigator's Choice of Chemotherapy in Patients With Platinum-resistant Recurrent Epithelial Ovarian Cancer(PANKU-GYN01) (clinicaltrials.gov)
    P3, N=384, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open • Platinum resistant
    |
    FOLR1 ( Folate receptor alpha )
    |
    paclitaxel • topotecan • izalontamab brengitecan (BL-B01D1)
    2ms
    BL-B01D1-302: A Study Comparing BL-B01D1 With Docetaxel in Patients With Unresectable Locally Advanced or Metastatic EGFR Wild-type Non-small Cell Lung Cancer(PANKU-Lung02) (clinicaltrials.gov)
    P3, N=698, Active, not recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Recruiting --> Active, not recruiting | Trial completion date: May 2026 --> Dec 2026 | Trial primary completion date: May 2026 --> Dec 2026
    Enrollment closed • Trial completion date • Trial primary completion date
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR wild-type
    |
    docetaxel • izalontamab brengitecan (BL-B01D1)
    2ms
    BL-B01D1-304: A Study Comparing BL-B01D1 With Topotecan in Patients With Recurrent Small Cell Lung Cancer(PANKU-Lung03) (clinicaltrials.gov)
    P3, N=722, Active, not recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Recruiting --> Active, not recruiting | Trial completion date: Jul 2026 --> Dec 2026 | Trial primary completion date: Jul 2026 --> Dec 2026
    Enrollment closed • Trial completion date • Trial primary completion date
    |
    topotecan • izalontamab brengitecan (BL-B01D1)