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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:
    11d
    A study protocol of a single-arm, prospective, open-label, non-controlled, phase II study of neoadjuvant BL-B01D1 combined with aumolertinib in resectable stage II-IIIB non-small cell lung cancer patients with EGFR mutation. (PubMed, Transl Lung Cancer Res)
    Registered on April 23, 2025. Protocol version: version 2.0, May 06, 2025.
    P2 data • Journal
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation
    |
    Ameile (aumolertinib) • izalontamab brengitecan (BL-B01D1)
    22d
    Rare Tumor Focused Platform Study of Innovative Therapies and Technologies (PLATFORM2) (clinicaltrials.gov)
    P1/2, N=600, Not yet recruiting, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
    New P1/2 trial • IO biomarker
    |
    izalontamab brengitecan (BL-B01D1) • MT027 • N201 • YSCH-01 • tirbanibulin oral (KX-01 oral)
    27d
    CA244-0001: A Study to Evaluate the Safety, Tolerability, Drug Levels, and Preliminary Efficacy of BMS-986507 Combinations in Adult Participants With Advanced Solid Tumors (clinicaltrials.gov)
    P1/2, N=416, Recruiting, Bristol-Myers Squibb | N=238 --> 416 | Trial completion date: Aug 2028 --> Feb 2031 | Trial primary completion date: Dec 2026 --> Feb 2031
    Enrollment change • Trial completion date • Trial primary completion date
    |
    Keytruda (pembrolizumab) • Opdivo (nivolumab) • Tagrisso (osimertinib) • pumitamig (BNT327) • izalontamab (SI-B001) • izalontamab brengitecan (BL-B01D1)
    1m
    BL-B01D1-LUNG-101: Evaluate BL-B01D1 in Patients With Metastatic or Unresectable Non-Small Cell Lung Cancer (NSCLC) and Other Solid Tumors (clinicaltrials.gov)
    P1, N=470, Recruiting, SystImmune Inc. | N=260 --> 470 | Trial primary completion date: Dec 2025 --> Dec 2026
    Enrollment change • Trial primary completion date
    |
    izalontamab brengitecan (BL-B01D1)
    2ms
    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) • axitinib • izalontamab (SI-B001) • izalontamab brengitecan (BL-B01D1)
    2ms
    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)
    2ms
    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)
    2ms
    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)
    2ms
    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)
    2ms
    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)
    3ms
    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)
    4ms
    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)