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    DRUG:

    izalontamab brengitecan (BL-B01D1)

    i
    Other names: BL-B01D1, Iza-can
    Company:
    BMS, Biokin Pharma
    Drug class:
    Topoisomerase I inhibitor, EGFR-targeted antibody-drug conjugate, HER3-targeted antibody-drug conjugate
    Related drugs:
    4d
    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)
    4d
    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)
    4d
    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)
    23d
    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)
    23d
    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)
    23d
    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)
    25d
    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)
    1m
    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)
    2ms
    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, Not yet recruiting, Sichuan Baili Pharmaceutical Co., Ltd.
    New P3 trial • Combination therapy • Metastases
    |
    paclitaxel • docetaxel • irinotecan • izalontamab brengitecan (BL-B01D1)
    2ms
    A Study of SI-B003 and BL-B01D1+SI-B003 in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer, Nasopharyngeal Carcinoma and Other Solid Tumors (clinicaltrials.gov)
    P2, N=121, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open • Combination therapy • Metastases
    |
    EGFR wild-type • EGFR wild-type + ALK wild-type
    |
    izalontamab brengitecan (BL-B01D1) • danvilostomig (SI-B003)
    4ms
    A Study of SI-B003 and BL-B01D1+SI-B003 in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer, Nasopharyngeal Carcinoma and Other Solid Tumors (clinicaltrials.gov)
    P2, N=121, Not yet recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | N=90 --> 121
    Enrollment change • Combination therapy • Metastases
    |
    EGFR wild-type • EGFR wild-type + ALK wild-type
    |
    izalontamab brengitecan (BL-B01D1) • danvilostomig (SI-B003)
    4ms
    A Study of SI-B003 and BL-B01D1+SI-B003 in Patients With Locally Advanced or Metastatic Urothelial Carcinoma and Other Solid Tumors (clinicaltrials.gov)
    P2, N=52, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open • Combination therapy • Metastases
    |
    izalontamab brengitecan (BL-B01D1) • danvilostomig (SI-B003)
    4ms
    A Study of SI-B003 or BL-B01D1+SI-B003 in Patients With Unresectable Locally Advanced or Recurrent Metastatic HER2 Negative Breast Cancer (clinicaltrials.gov)
    P2, N=58, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open • Combination therapy • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative
    |
    izalontamab brengitecan (BL-B01D1) • danvilostomig (SI-B003)
    4ms
    A Study of BL-B01D1+SI-B003 in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer, Nasopharyngeal Carcinoma and Other Solid Tumors (clinicaltrials.gov)
    P2, N=90, Not yet recruiting, Sichuan Baili Pharmaceutical Co., Ltd.
    Trial completion date • Trial initiation date • Trial primary completion date • Metastases
    |
    EGFR wild-type • EGFR wild-type + ALK wild-type
    |
    izalontamab brengitecan (BL-B01D1) • danvilostomig (SI-B003)
    4ms
    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=98, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | N=50 --> 98
    Enrollment change • Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    HRD (Homologous Recombination Deficiency) • BRCA (Breast cancer early onset)
    |
    HRD • BRCA mutation
    |
    izalontamab brengitecan (BL-B01D1) • danvilostomig (SI-B003)
    5ms
    A Study Comparing BL-B01D1 With Physician's Choice of Chemotherapy in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma (clinicaltrials.gov)
    P3, N=368, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    PD-L1 (Programmed death ligand 1)
    |
    gemcitabine • docetaxel • capecitabine • izalontamab brengitecan (BL-B01D1)
    5ms
    A Study of BL-B01D1 in Patients With Multiple Solid Tumors, Including Locally Advanced or Metastatic Urinary System Tumors (clinicaltrials.gov)
    P2, N=32, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Phase classification: P2a/2b --> P2
    Phase classification
    |
    izalontamab brengitecan (BL-B01D1)
    5ms
    A Study of SI-B003 and BL-B01D1+SI-B003 in Patients With Locally Advanced or Metastatic Esophageal Cancer, Gastric Cancer, Colorectal Cancer and Other Gastrointestinal Tumors (clinicaltrials.gov)
    P2, N=190, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open • Trial completion date • Trial initiation date • Trial primary completion date • Combination therapy • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HER-2 negative
    |
    izalontamab brengitecan (BL-B01D1) • danvilostomig (SI-B003)
    5ms
    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: Dec 2023 --> Mar 2024 | Trial primary completion date: Nov 2023 --> Mar 2024
    Trial completion date • Trial primary completion date • Metastases
    |
    TACSTD2 (Tumor Associated Calcium Signal Transducer 2)
    |
    izalontamab brengitecan (BL-B01D1)
    5ms
    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: Dec 2023 --> Mar 2024 | Trial primary completion date: Dec 2023 --> Mar 2024
    Trial completion date • Trial primary completion date • Metastases
    |
    izalontamab brengitecan (BL-B01D1)
    5ms
    A Study of BL-B01D1, SI-B003 and BL-B01D1+SI-B003 in Treatment of Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (Non-nasopharyngeal Carcinoma) and Other Solid Tumors (clinicaltrials.gov)
    P2, N=160, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Not yet recruiting --> Recruiting | N=100 --> 160
    Enrollment open • Enrollment change
    |
    izalontamab brengitecan (BL-B01D1) • danvilostomig (SI-B003)
    5ms
    A Study of BL-B01D1, SI-B003 and BL-B01D1+SI-B003 in the Treatment of Patients With Extensive Stage Small Cell Lung Cancer (clinicaltrials.gov)
    P2, N=100, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Not yet recruiting --> Recruiting | Trial completion date: Jul 2025 --> Nov 2025 | Initiation date: Jul 2023 --> Nov 2023 | Trial primary completion date: Jul 2025 --> Nov 2025
    Enrollment open • Trial completion date • Trial initiation date • Trial primary completion date • Combination therapy
    |
    izalontamab brengitecan (BL-B01D1) • danvilostomig (SI-B003)
    5ms
    A Study of SI-B003 and BL-B01D1+SI-B003 in Patients With Locally Advanced or Recurrent Metastatic HER-2 Negative Breast Cancer (clinicaltrials.gov)
    P2, N=58, Not yet recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | N=40 --> 58
    Enrollment change
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative
    |
    izalontamab brengitecan (BL-B01D1) • danvilostomig (SI-B003)
    5ms
    A Study of SI-B003 and BL-B01D1+SI-B003 in the Treatment of Patients With Locally Advanced or Metastatic Urothelial Carcinoma and Other Solid Tumors (clinicaltrials.gov)
    P2, N=52, Not yet recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | N=40 --> 52 | Trial completion date: Aug 2025 --> Dec 2025 | Initiation date: Aug 2023 --> Dec 2023 | Trial primary completion date: Aug 2025 --> Dec 2025
    Enrollment change • Trial completion date • Trial initiation date • Trial primary completion date • Combination therapy • Metastases
    |
    izalontamab brengitecan (BL-B01D1) • danvilostomig (SI-B003)
    6ms
    A Study of BL-B01D1, SI-B003 and BL-B01D1+SI-B003 in the Treatment of Recurrent or Metastatic Cervical Cancer and Other Gynecological Malignancies (clinicaltrials.gov)
    P2, N=50, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open • Combination therapy • Metastases
    |
    HRD (Homologous Recombination Deficiency) • BRCA (Breast cancer early onset)
    |
    HRD • BRCA mutation
    |
    izalontamab brengitecan (BL-B01D1) • danvilostomig (SI-B003)
    6ms
    A Study Comparing BL-B01D1 With Physician's Choice of Chemotherapy in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma (clinicaltrials.gov)
    P3, N=368, Not yet recruiting, Sichuan Baili Pharmaceutical Co., Ltd.
    New P3 trial • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    gemcitabine • docetaxel • capecitabine • izalontamab brengitecan (BL-B01D1)
    7ms
    A Study of SI-B003 or BL-B01D1+SI-B003 in Patients With Unresectable Locally Advanced or Recurrent Metastatic HER2 Negative Breast Cancer (clinicaltrials.gov)
    P2, N=40, Not yet recruiting, Sichuan Baili Pharmaceutical Co., Ltd.
    New P2 trial • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative
    |
    izalontamab brengitecan (BL-B01D1) • danvilostomig (SI-B003)
    8ms
    A Study of BL-B01D1 Combined With Osimertinib Mesylate Tablets in Patients With Non-small Cell Lung Cancer (clinicaltrials.gov)
    P2, N=42, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open • Combination therapy • Metastases
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion
    |
    Tagrisso (osimertinib) • izalontamab brengitecan (BL-B01D1)
    8ms
    A Study of SI-B003 and BL-B01D1+SI-B003 in the Treatment of Patients With Locally Advanced or Metastatic Esophageal Cancer, Gastric Cancer, Colorectal Cancer and Other Gastrointestinal Tumors (clinicaltrials.gov)
    P2, N=190, Not yet recruiting, Sichuan Baili Pharmaceutical Co., Ltd.
    New P2 trial • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HER-2 negative
    |
    izalontamab brengitecan (BL-B01D1) • danvilostomig (SI-B003)
    9ms
    A Study of BL-B01D1, SI-B003 and BL-B01D1+SI-B003 in the Treatment of Recurrent or Metastatic Cervical Cancer and Other Gynecological Malignancies (clinicaltrials.gov)
    P2, N=50, Not yet recruiting, Sichuan Baili Pharmaceutical Co., Ltd.
    New P2 trial • Combination therapy • Metastases
    |
    HRD (Homologous Recombination Deficiency) • BRCA (Breast cancer early onset)
    |
    HRD • BRCA mutation
    |
    izalontamab brengitecan (BL-B01D1) • danvilostomig (SI-B003)
    9ms
    A Study of BL-B01D1+SI-B003 in the Treatment of Locally Advanced or Metastatic Non-small Cell Lung Cancer, Nasopharyngeal Carcinoma and Other Solid Tumors (clinicaltrials.gov)
    P2, N=90, Not yet recruiting, Sichuan Baili Pharmaceutical Co., Ltd.
    New P2 trial • Metastases
    |
    EGFR wild-type • EGFR wild-type + ALK wild-type
    |
    izalontamab brengitecan (BL-B01D1) • danvilostomig (SI-B003)
    10ms
    A Study of BL-B01D1 Monotherapy and BL-B01D1+SI-B003 Combination Therapy in Patients With Extensive Stage Small Cell Lung Cancer (clinicaltrials.gov)
    P2, N=100, Not yet recruiting, Sichuan Baili Pharmaceutical Co., Ltd.
    New P2 trial • Combination therapy
    |
    izalontamab brengitecan (BL-B01D1) • danvilostomig (SI-B003)
    11ms
    A Study of BL-B01D1 Combined With Osimertinib Mesylate Tablets in Patients With Non-small Cell Lung Cancer (clinicaltrials.gov)
    P2, N=42, Not yet recruiting, Sichuan Baili Pharmaceutical Co., Ltd.
    New P2 trial • Combination therapy • Metastases
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion
    |
    Tagrisso (osimertinib) • izalontamab brengitecan (BL-B01D1)
    12ms
    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. | Active, not recruiting --> Recruiting
    Enrollment open • Metastases
    |
    izalontamab brengitecan (BL-B01D1)
    12ms
    A Clinical Study of BL-B01D1 in Patients With Multiple Solid Tumors Such as Locally Advanced or Metastatic Urinary System Tumors (clinicaltrials.gov)
    P2a/2b, N=32, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    izalontamab brengitecan (BL-B01D1)
    12ms
    A Clinical Study of BL-B01D1 in Patients With Multiple Solid Tumors Such as Recurrent or Metastatic Gynecological Malignancies (clinicaltrials.gov)
    P1/2, N=32, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Not yet recruiting --> Recruiting | Trial primary completion date: May 2023 --> May 2025
    Enrollment open • Trial primary completion date
    |
    izalontamab brengitecan (BL-B01D1)
    1year
    BL-B01D1, a novel EGFR×HER3-targeting ADC, demonstrates robust anti-tumor efficacy in preclinical evaluation (AACR 2023)
    It is comprised of a bispecific antibody against EGFR/HER3 (SI-B001), a cathepsin B cleavable linker, and a novel topoisomerase I inhibitor agent (Ed-04), which is a derivative of the alkaloid camptothecin, driving cell cycle arrest at the S phase and subsequent apoptosis. The clinical phase I has been progressing and the available data exhibit excellent efficacy but low levels of targeted toxicity in the non-small cell lung cancer (NSCLC) treatment setting. Overall, these data suggest BL-B01D1 has potential to serve as a novel, efficacious therapeutic agent for NSCLC with similar therapeutic impact as DS-8201 has in breast cancer treatment.
    Preclinical
    |
    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • ERBB3 (V-erb-b2 avian erythroblastic leukemia viral oncogene homolog 3)
    |
    Enhertu (fam-trastuzumab deruxtecan-nxki) • izalontamab (SI-B001) • izalontamab brengitecan (BL-B01D1) • R3Mab