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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:
    13d
    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)
    28d
    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
    1m
    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)
    1m
    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)
    2ms
    BL-B01D1-209: A Study of BL-B01D1 in Patients With Locally Advanced or Metastatic Chordoma (clinicaltrials.gov)
    P2, N=27, Active, not recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Recruiting --> Active, not recruiting | N=40 --> 27
    Enrollment closed • Enrollment change
    |
    izalontamab brengitecan (BL-B01D1)
    2ms
    EGFR- and HER3-targeted bispecific antibody-drug conjugate demonstrates anti-tumor activity in metastatic castration-resistant prostate cancer. (PubMed, J Clin Invest)
    Izalontamab brengitecan (Iza-bren; BL-B01D1) is a bispecific ADC targeting EGFR and HER3 that has demonstrated activity in other malignancies. Importantly, tumor tissue obtained at progression after BL-B01D1 treatment confirmed ABCG2 upregulation, validating a clinically relevant resistance mechanism. These findings support BL-B01D1 as a promising therapeutic strategy in mCRPC and nominate ABCG2 as a rational target for overcoming resistance.
    Journal
    |
    EGFR (Epidermal growth factor receptor) • ERBB3 (V-erb-b2 avian erythroblastic leukemia viral oncogene homolog 3) • ABCG2 (ATP Binding Cassette Subfamily G Member 2)
    |
    EGFR expression
    |
    izalontamab (SI-B001) • izalontamab brengitecan (BL-B01D1)
    2ms
    A Study Comparing BL-B01D1 Combined With Tislelizumab Versus Platinum-containing Chemotherapy Combined With Tislelizumab as First-line Treatment in Patients With Extensive-stage Small Cell Lung Cance (clinicaltrials.gov)
    P3, N=562, Not yet recruiting, Sichuan Baili Pharmaceutical Co., Ltd.
    New P3 trial
    |
    carboplatin • Tevimbra (tislelizumab-jsgr) • etoposide IV • izalontamab (SI-B001) • izalontamab brengitecan (BL-B01D1)
    3ms
    Recent highlights and breakthroughs in immunotherapy for head and neck cancers. (PubMed, Curr Opin Oncol)
    Recent advances highlight a rapid surge in positive immunotherapy trials across different head and neck cancer entities, with clinical benefit observed both when immune checkpoint inhibitors are moved earlier in the disease course and when they are combined with agents targeting resistance mechanisms or enabling more precise drug delivery to tumors.
    Journal • PD(L)-1 Biomarker • IO biomarker
    |
    BRAF (B-raf proto-oncogene)
    |
    BRAF V600E • BRAF V600
    |
    Keytruda (pembrolizumab) • Opdivo (nivolumab) • Erbitux (cetuximab) • Mekinist (trametinib) • Tafinlar (dabrafenib) • Bavencio (avelumab) • Loqtorzi (toripalimab-tpzi) • AiRuiKa (camrelizumab) • Padcev (enfortumab vedotin-ejfv) • Meiyouheng (becotatug vedotin) • ficerafusp alfa (BCA101) • petosemtamab (MCLA-158) • becotarug (JMT101) • izalontamab (SI-B001) • izalontamab brengitecan (BL-B01D1) • Cotelet (tagitanlimab)
    3ms
    Izalontamab Brengitecan in Locally Advanced or Metastatic Non-Small Cell Lung Cancer With Actionable Genomic Alterations Outside of Classical EGFR Mutations: A Phase Ib Study. (PubMed, J Clin Oncol)
    iza-bren demonstrated encouraging antitumor activity and a manageable safety profile in pretreated NSCLC patients with diverse GAs outside of classical EGFR mutations, especially in EGFR exon20ins/nonclassical and HER2 mutations.
    P1 data • Journal
    |
    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) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • NTRK (Neurotrophic receptor tyrosine kinase)
    |
    KRAS mutation • EGFR mutation • BRAF mutation • RET fusion • EGFR exon 20 insertion • RET mutation • ROS1 fusion • MET mutation • EGFR exon 20 mutation • NTRK fusion
    |
    izalontamab (SI-B001) • izalontamab brengitecan (BL-B01D1)