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    DRUG:

    izalontamab (SI-B001)

    i
    Other names: SI-B001
    Company:
    Biokin Pharma
    Drug class:
    EGFR inhibitor, HER3 inhibitor
    Related drugs:
    3d
    Phase 1 Study Of Izalontamab Brengitecan + Adagrasib In NSCLC - The IZA-A Trial (clinicaltrials.gov)
    P1, N=18, Not yet recruiting, M.D. Anderson Cancer Center
    New P1 trial
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    KRAS mutation
    |
    Krazati (adagrasib) • izalontamab (SI-B001) • izalontamab brengitecan (BL-B01D1)
    8d
    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)
    15d
    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)
    16d
    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)
    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)
    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)
    3ms
    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)
    3ms
    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)
    3ms
    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)
    4ms
    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)