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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:
    3d
    Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetic Profile, and Preliminary Efficacy of BL-B01D1 for Injection in Patients with Locally Advanced or Metastatic Solid Tumors (ChiCTR2500113663)
    P1, N=500, Not yet recruiting, Sun Yat-sen University Cancer Center; Sichuan Baili Pharmaceutical Co., Ltd.
    New P1 trial
    |
    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • MET (MET proto-oncogene, receptor tyrosine kinase) • RET (Ret Proto-Oncogene) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • NTRK (Neurotrophic receptor tyrosine kinase)
    |
    BRAF V600E • KRAS mutation • EGFR mutation • KRAS G12C • BRAF V600 • RET fusion • MET exon 14 mutation • ALK fusion • EGFR L861Q • RET mutation • ROS1 fusion • EGFR G719X • MET mutation • EGFR S768I • KRAS G12 • NTRK fusion
    |
    izalontamab brengitecan (BL-B01D1)
    4d
    Izalontamab brengitecan (Iza-bren; BL-B01D1), a first-in-class EGFR-HER3 bispecific antibody-drug conjugate, for patients with EGFR-mutated NSCLC: Pooled analysis of phase 1 and phase 2 trials. (PubMed, Ann Oncol)
    In this exploratory post hoc pooled analysis, Iza-bren demonstrated promising antitumor activity and a manageable safety profile in heavily pretreated EGFR-mutated NSCLC. These findings are hypothesis-generating and are being further evaluated in ongoing randomized trials.
    P1 data • P2 data • Retrospective data • Journal
    |
    ERBB3 (V-erb-b2 avian erythroblastic leukemia viral oncogene homolog 3)
    |
    EGFR mutation
    |
    izalontamab (SI-B001) • izalontamab brengitecan (BL-B01D1)
    10d
    Recent advances in bispecific antibody-drug conjugates for breast cancer therapy. (PubMed, Cancer Chemother Pharmacol)
    BsADCs are a transformative therapeutic modality for breast cancer. Their ability to enhance tumor selectivity, overcome heterogeneity, and target resistant pathways positions them as key players in the future oncology landscape, with ongoing trials poised to define their clinical role.
    Review • Journal
    |
    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • ERBB3 (V-erb-b2 avian erythroblastic leukemia viral oncogene homolog 3)
    |
    HER-2 expression
    |
    zanidatamab zovodotin (ZW49) • izalontamab brengitecan (BL-B01D1) • anbenitamab repodatecan (JSKN003)
    12d
    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=96, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | N=206 --> 96
    Enrollment change
    |
    PD-L1 (Programmed death ligand 1)
    |
    Keytruda (pembrolizumab) • Avastin (bevacizumab) • izalontamab (SI-B001) • izalontamab brengitecan (BL-B01D1)
    12d
    BL-B01D1-204-05: A Study of BL-B01D1+PD-1 Monoclonal Antibody in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer, Nasopharyngeal Carcinoma and Other Solid Tumors (clinicaltrials.gov)
    P2, N=570, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | N=332 --> 570
    Enrollment change
    |
    izalontamab (SI-B001) • izalontamab brengitecan (BL-B01D1)
    25d
    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)
    1m
    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)
    1m
    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)
    2ms
    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)
    3ms
    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)
    3ms
    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)
    3ms
    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)