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    DRUG:

    izalontamab brengitecan (BL-B01D1)

    i
    Other names: BL-B01D1, Iza-can, BLB01D1, BL B01D1
    Company:
    BMS, Biokin Pharma
    Drug class:
    Topoisomerase I inhibitor, EGFR-targeted antibody-drug conjugate, HER3-targeted antibody-drug conjugate
    Related drugs:
    21d
    A Study of BL-B01D1 in Patients With Recurrent Glioblastoma (clinicaltrials.gov)
    P2, N=20, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    izalontamab brengitecan (BL-B01D1)
    26d
    A Study of BL-B01D1, SI-B003 and BL-B01D1+SI-B003 in Patients With Recurrent or Metastatic Cervical Cancer and Other Gynecological Malignancies (clinicaltrials.gov)
    P2, N=130, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | N=98 --> 130
    Enrollment change • Combination therapy • Metastases
    |
    HRD (Homologous Recombination Deficiency) • BRCA (Breast cancer early onset)
    |
    HRD • BRCA mutation
    |
    izalontamab brengitecan (BL-B01D1) • danvilostomig (SI-B003)
    1m
    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=332, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | N=126 --> 332
    Enrollment change • Metastases
    |
    izalontamab brengitecan (BL-B01D1)
    1m
    A Study of BL-B01D1 in Patients With Locally Advanced or Metastatic Urological Tumors and Other Solid Tumors (clinicaltrials.gov)
    P1, N=26, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Trial completion date: Aug 2024 --> Jun 2025 | Trial primary completion date: Aug 2024 --> Jun 2025
    Trial completion date • Trial primary completion date • Metastases
    |
    izalontamab brengitecan (BL-B01D1)
    2ms
    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=218, Not yet recruiting, Bristol-Myers Squibb
    New P1/2 trial
    |
    Keytruda (pembrolizumab) • Tagrisso (osimertinib) • izalontamab brengitecan (BL-B01D1)
    2ms
    A Study of SI-B003, BL-B01D1+SI-B003 and BL-B01D1+PD-1 Monoclonal Antibody in Patients With Locally Advanced or Metastatic Esophageal Cancer, Gastric Cancer, Colorectal Cancer and Other Gastrointestinal Tumors (clinicaltrials.gov)
    P2, N=376, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | N=268 --> 376
    Enrollment change • Combination therapy • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HER-2 negative
    |
    izalontamab brengitecan (BL-B01D1) • danvilostomig (SI-B003)
    2ms
    BL-B01D1-204-01: A Study of BL-B01D1+PD-1 Monoclonal Antibody in Patients With Extensive-stage Small Cell Lung Cancer (clinicaltrials.gov)
    P2, N=66, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | N=36 --> 66
    Enrollment change
    |
    izalontamab brengitecan (BL-B01D1)
    2ms
    A Study of BL-B01D1 in Patients With Multiple Solid Tumors, Including Locally Advanced or Metastatic Urinary System Tumors (clinicaltrials.gov)
    P2, N=76, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | N=32 --> 76
    Enrollment change • Metastases
    |
    izalontamab brengitecan (BL-B01D1)
    2ms
    A Study of BL-B01D1 in Patients With Recurrent Glioblastoma (clinicaltrials.gov)
    P2, N=20, Not yet recruiting, Sichuan Baili Pharmaceutical Co., Ltd.
    New P2 trial
    |
    izalontamab brengitecan (BL-B01D1)
    2ms
    A Study of BL-B01D1 in Patients With Locally Advanced or Metastatic Gastrointestinal Tumor and Other Solid Tumor (clinicaltrials.gov)
    P1, N=96, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Trial completion date: Aug 2024 --> Dec 2024 | Trial primary completion date: Aug 2024 --> Dec 2024
    Trial completion date • Trial primary completion date • Metastases
    |
    TACSTD2 (Tumor Associated Calcium Signal Transducer 2)
    |
    izalontamab brengitecan (BL-B01D1)
    2ms
    BL-B01D1-101: A Study of BL-B01D1 in Patients With Locally Advanced or Metastatic Solid Tumor (clinicaltrials.gov)
    P1, N=96, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Trial completion date: Aug 2024 --> Dec 2024 | Trial primary completion date: Aug 2024 --> Dec 2024
    Trial completion date • Trial primary completion date • Metastases
    |
    izalontamab brengitecan (BL-B01D1)
    2ms
    A Study of BL-B01D1 in Patients With Unresectable Locally Advanced or Metastatic Breast Cancer and Other Solid Tumors (clinicaltrials.gov)
    P1, N=36, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Trial completion date: Aug 2024 --> Dec 2024 | Trial primary completion date: Aug 2024 --> Dec 2024
    Trial completion date • Trial primary completion date • Metastases
    |
    izalontamab brengitecan (BL-B01D1)
    3ms
    A Study of BL-B01D1+PD-1 Monoclonal Antibody in Patients With Unresectable Locally Advanced or Recurrent Metastatic Triple-negative Breast Cancer (clinicaltrials.gov)
    P2, N=52, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open • Combination therapy • Metastases
    |
    izalontamab brengitecan (BL-B01D1)
    3ms
    BL-B01D1-304: A Study Comparing BL-B01D1 With Topotecan in Patients With Recurrent Small Cell Lung Cancer (clinicaltrials.gov)
    P3, N=652, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    topotecan • izalontamab brengitecan (BL-B01D1)
    3ms
    BL-B01D1-204-02: A Study of BL-B01D1+PD-1 Monoclonal Antibody in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma and Other Solid Tumors (clinicaltrials.gov)
    P2, N=52, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    |
    izalontamab brengitecan (BL-B01D1)
    3ms
    A Study of BL-B01D1 in Combination With Osimertinib Mesylate Tablets in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (clinicaltrials.gov)
    P2, N=40, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open • Combination therapy • Metastases
    |
    Tagrisso (osimertinib) • izalontamab brengitecan (BL-B01D1)
    3ms
    A Study of BL-B01D1 and BL-B01D1 in Combination With Osimertinib Mesylate Tablets in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (clinicaltrials.gov)
    P2, N=114, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | N=42 --> 114
    Enrollment change • Combination therapy • Metastases
    |
    EGFR (Epidermal growth factor receptor)
    |
    Tagrisso (osimertinib) • izalontamab brengitecan (BL-B01D1)
    4ms
    BL-B01D1-204-01: A Study of BL-B01D1+PD-1 Monoclonal Antibody in Patients With Extensive-stage Small Cell Lung Cancer (clinicaltrials.gov)
    P2, N=36, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Not yet recruiting --> Recruiting | N=60 --> 36
    Enrollment open • Enrollment change
    |
    izalontamab brengitecan (BL-B01D1)
    4ms
    Study to Evaluate BL-B01D1 in Patients With Metastatic or Unresectable Non-Small Cell Lung Cancer (NSCLC) and Other Solid Tumors (clinicaltrials.gov)
    P1, N=260, Recruiting, SystImmune Inc. | Trial completion date: Sep 2025 --> Mar 2028 | Trial primary completion date: Jul 2024 --> Dec 2025
    Trial completion date • Trial primary completion date • Metastases
    |
    izalontamab brengitecan (BL-B01D1)
    4ms
    A Study Comparing BL-B01D1 With Topotecan in Patients With Recurrent Small Cell Lung Cancer (clinicaltrials.gov)
    P3, N=652, Not yet recruiting, Sichuan Baili Pharmaceutical Co., Ltd.
    New P3 trial
    |
    topotecan • izalontamab brengitecan (BL-B01D1)
    4ms
    A Study of BL-B01D1 in Combination With Osimertinib Mesylate Tablets in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (clinicaltrials.gov)
    P2, N=40, Not yet recruiting, Sichuan Baili Pharmaceutical Co., Ltd.
    New P2 trial • Combination therapy • Metastases
    |
    Tagrisso (osimertinib) • izalontamab brengitecan (BL-B01D1)
    4ms
    BL-B01D1-204-03: A Study of BL-B01D1 + PD-1 in Patients With Locally Advanced or Metastatic Urothelial Carcinoma (clinicaltrials.gov)
    P2, N=52, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open • Combination therapy • Metastases
    |
    izalontamab brengitecan (BL-B01D1)
    5ms
    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=126, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    |
    izalontamab brengitecan (BL-B01D1)
    5ms
    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=436, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    |
    gemcitabine • capecitabine • Halaven (eribulin mesylate) • vinorelbine tartrate • izalontamab brengitecan (BL-B01D1)
    5ms
    A Study of SI-B003, BL-B01D1+SI-B003 and BL-B01D1+PD-1 Monoclonal Antibody in Patients With Locally Advanced or Metastatic Esophageal Cancer, Gastric Cancer, Colorectal Cancer and Other Gastrointestinal Tumors (clinicaltrials.gov)
    P2, N=268, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | N=190 --> 268
    Enrollment change • Combination therapy • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    izalontamab brengitecan (BL-B01D1) • danvilostomig (SI-B003)
    5ms
    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=126, Not yet recruiting, Sichuan Baili Pharmaceutical Co., Ltd.
    New P2 trial • Metastases
    |
    izalontamab brengitecan (BL-B01D1)
    5ms
    A Study of BL-B01D1+PD-1 Monoclonal Antibody in Patients With Unresectable Locally Advanced or Recurrent Metastatic Triple-negative Breast Cancer (clinicaltrials.gov)
    P2, N=52, Not yet recruiting, Sichuan Baili Pharmaceutical Co., Ltd.
    New P2 trial • Combination therapy • Metastases
    |
    izalontamab brengitecan (BL-B01D1)
    6ms
    A Study Comparing BL-B01D1 With Docetaxel in Patients With Unresectable Locally Advanced or Metastatic EGFR Wild-type Non-small Cell Lung Cancer (clinicaltrials.gov)
    P3, N=558, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    |
    docetaxel • izalontamab brengitecan (BL-B01D1)
    6ms
    A Study of BL-B01D1+PD-1 Monoclonal Antibody in Patients With Extensive-stage Small Cell Lung Cancer (clinicaltrials.gov)
    P2, N=60, Not yet recruiting, Sichuan Baili Pharmaceutical Co., Ltd.
    New P2 trial
    |
    izalontamab brengitecan (BL-B01D1)
    6ms
    A Study of BL-B01D1+PD-1 Monoclonal Antibody in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma and Other Solid Tumors (clinicaltrials.gov)
    P2, N=52, Not yet recruiting, Sichuan Baili Pharmaceutical Co., Ltd.
    New P2 trial • Metastases
    |
    izalontamab brengitecan (BL-B01D1)
    6ms
    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=428, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    |
    cisplatin • carboplatin • pemetrexed • izalontamab brengitecan (BL-B01D1)
    6ms
    A Study Comparing BL-B01D1 With Chemotherapy of Physician's Choice in Patients With Unresectable Locally Advanced, Recurrent, or Metastatic HR+HER2- Breast Cancer (clinicaltrials.gov)
    P3, N=382, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    |
    gemcitabine • capecitabine • Halaven (eribulin mesylate) • vinorelbine tartrate • izalontamab brengitecan (BL-B01D1)
    6ms
    A Study of BL-B01D1 + PD-1 in Patients With Locally Advanced or Metastatic Urothelial Carcinoma (clinicaltrials.gov)
    P2, N=52, Not yet recruiting, Sichuan Baili Pharmaceutical Co., Ltd.
    New P2 trial • Combination therapy • Metastases
    |
    izalontamab brengitecan (BL-B01D1)
    7ms
    Study to Evaluate BL-B01D1 in Patients With Metastatic or Unresectable Non-Small Cell Lung Cancer (NSCLC) and Other Solid Tumors (clinicaltrials.gov)
    P1, N=260, Recruiting, SystImmune Inc. | N=100 --> 260
    Enrollment change • Metastases
    |
    izalontamab brengitecan (BL-B01D1)
    7ms
    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=436, Not yet recruiting, Sichuan Baili Pharmaceutical Co., Ltd.
    New P3 trial • Metastases
    |
    gemcitabine • capecitabine • Halaven (eribulin mesylate) • vinorelbine tartrate • izalontamab brengitecan (BL-B01D1)
    7ms
    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=428, Not yet recruiting, Sichuan Baili Pharmaceutical Co., Ltd.
    New P3 trial • Metastases
    |
    cisplatin • carboplatin • pemetrexed • izalontamab brengitecan (BL-B01D1)
    7ms
    A Study Comparing BL-B01D1 With Docetaxel in Patients With Unresectable Locally Advanced or Metastatic EGFR Wild-type Non-small Cell Lung Cancer (clinicaltrials.gov)
    P3, N=558, Not yet recruiting, Sichuan Baili Pharmaceutical Co., Ltd.
    New P3 trial • Metastases
    |
    docetaxel • izalontamab brengitecan (BL-B01D1)
    8ms
    A Study of BL-B01D1 in Patients With Locally Advanced or Metastatic Urological Tumors and Other Solid Tumors (clinicaltrials.gov)
    P1, N=26, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Trial completion date: Feb 2024 --> Aug 2024 | Trial primary completion date: Feb 2024 --> Aug 2024
    Trial completion date • Trial primary completion date • Metastases
    |
    izalontamab brengitecan (BL-B01D1)
    8ms
    A Study of BL-B01D1 in Patients With Locally Advanced or Metastatic Solid Tumor (clinicaltrials.gov)
    P1, N=96, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Trial completion date: Mar 2024 --> Aug 2024 | Trial primary completion date: Mar 2024 --> Aug 2024
    Trial completion date • Trial primary completion date • Metastases
    |
    izalontamab brengitecan (BL-B01D1)
    8ms
    A Study of BL-B01D1 in Patients With Locally Advanced or Metastatic Gastrointestinal Tumor and Other Solid Tumor (clinicaltrials.gov)
    P1, N=96, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Trial completion date: Mar 2024 --> Aug 2024 | Trial primary completion date: Mar 2024 --> Aug 2024
    Trial completion date • Trial primary completion date • Metastases
    |
    TACSTD2 (Tumor Associated Calcium Signal Transducer 2)
    |
    izalontamab brengitecan (BL-B01D1)
    8ms
    A Study Comparing BL-B01D1 With Chemotherapy of Physician's Choice in Patients With Unresectable Locally Advanced, Recurrent, or Metastatic HR+HER2- Breast Cancer (clinicaltrials.gov)
    P3, N=382, Not yet recruiting, Sichuan Baili Pharmaceutical Co., Ltd.
    New P3 trial
    |
    gemcitabine • capecitabine • Halaven (eribulin mesylate) • vinorelbine tartrate • izalontamab brengitecan (BL-B01D1)
    8ms
    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=488, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open • Combination therapy • Metastases
    |
    paclitaxel • docetaxel • irinotecan • izalontamab brengitecan (BL-B01D1)