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    DRUG CLASS:

    HER3-targeted antibody-drug conjugate

    Related drugs:
    2ms
    BL-B01D1-303: A Phase III clinical trial comparing BL-B01D1 with physician-selected chemotherapy regimens (last line) in patients with recurrent or metastatic nasopharyngeal carcinoma who had previously received PD-1/PD-L1 monoclonal antibody therapy and failed at least two lines of chemotherapy. (clinicaltrials.gov)
    P3, N=386, Active, not recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | -> Active, not recruiting | Phase classification: PN/A --> P3
    Enrollment closed • Phase classification
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    PD-L1 (Programmed death ligand 1)
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    gemcitabine • docetaxel • capecitabine • izalontamab brengitecan (BL-B01D1)
    2ms
    A Clinical Study of SYS6023 Combination Therapy for Advanced Breast Cancer (clinicaltrials.gov)
    P2, N=36, Recruiting, CSPC Megalith Biopharmaceutical Co.,Ltd. | Not yet recruiting --> Recruiting | N=114 --> 36
    Enrollment open • Enrollment change
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    Ennituo (anbenitamab)
    2ms
    Pivotal Study to Evaluate YL202 Versus Docetaxel in Patients With Locally Advanced or Metastatic EGFR Sensitive Mutation Non-Squamous Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P3, N=440, Recruiting, MediLink Therapeutics (Suzhou) Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open
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    EGFR mutation • EGFR L858R • EGFR exon 19 deletion
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    docetaxel • BNT326
    2ms
    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
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    HER-2 (Human epidermal growth factor receptor 2)
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    HER-2 negative
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    capecitabine • albumin-bound paclitaxel • izalontamab brengitecan (BL-B01D1)
    2ms
    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
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    EGFR (Epidermal growth factor receptor)
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    EGFR mutation
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    Tagrisso (osimertinib) • izalontamab brengitecan (BL-B01D1)
    2ms
    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
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    EGFR (Epidermal growth factor receptor)
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    EGFR mutation
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    cisplatin • Tagrisso (osimertinib) • carboplatin • pemetrexed • izalontamab brengitecan (BL-B01D1)
    2ms
    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
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    Lynparza (olaparib) • abiraterone acetate • izalontamab brengitecan (BL-B01D1)
    2ms
    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
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    Avastin (bevacizumab) • Lenvima (lenvatinib) • izalontamab brengitecan (BL-B01D1) • Anyouping (finotonlimab)
    2ms
    HERTHENA-Lung01: Patritumab Deruxtecan in Subjects With Metastatic or Locally Advanced EGFR-mutated Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P2, N=277, Active, not recruiting, Daiichi Sankyo | Trial completion date: Jul 2026 --> Jan 2027
    Trial completion date
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    ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
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    EGFR mutation • EGFR L858R • EGFR exon 19 deletion • ROS1 fusion
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    patritumab deruxtecan (U3-1402)
    2ms
    A Study of AK138D1 Alone or in Combination With Ivonescimab in Advanced Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P1/2, N=265, Not yet recruiting, Akeso
    New P1/2 trial
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    carboplatin • Idafang (ivonescimab)
    2ms
    A Phase I Study of CS5007 in Participants With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=310, Not yet recruiting, CStone Pharmaceuticals
    New P1 trial • First-in-human
    2ms
    A Phase I Study of JSKN021 in Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=199, Not yet recruiting, Jiangsu Alphamab Biopharmaceuticals Co., Ltd
    New P1 trial • First-in-human