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    DRUG:

    danvilostomig (SI-B003)

    i
    Other names: SI-B003
    Associations

    News

    Trials
    Company:
    Biokin Pharma
    Drug class:
    PD1 inhibitor, CTLA4 inhibitor
    Related drugs:
    Associations

    News

    Trials
    3ms
    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)
    3ms
    A Study of SI-B003, a PD-1/CTLA-4 Bispecific Antibody, in Patients With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=159, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Trial completion date: Dec 2023 --> May 2024 | Trial primary completion date: Dec 2023 --> May 2024
    Trial completion date • Trial primary completion date • Metastases
    |
    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)
    5ms
    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)
    5ms
    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 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, 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-B001+SI-B003± Chemotherapy in the Treatment of Locally Advanced or Metastatic Non-small Cell Lung Cancer (clinicaltrials.gov)
    P1/2, N=160, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Not yet recruiting --> Recruiting | Trial completion date: Aug 2025 --> Nov 2025 | Initiation date: Aug 2023 --> Oct 2023 | Trial primary completion date: Aug 2025 --> Nov 2025
    Enrollment open • Trial completion date • Trial initiation date • Trial primary completion date • Metastases
    |
    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)
    |
    BRAF mutation • BRAF V600 • EGFR wild-type • MET exon 14 mutation • ALK fusion • RET mutation • ROS1 fusion • ROS1 rearrangement • RET rearrangement • NTRK fusion
    |
    izalontamab (SI-B001) • 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 of SI-B003, a PD-1/CTLA-4 Bispecific Antibody, in Patients With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=159, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Trial completion date: Sep 2023 --> Dec 2023 | Trial primary completion date: Sep 2023 --> Dec 2023
    Trial completion date • Trial primary completion date • Metastases
    |
    danvilostomig (SI-B003)
    8ms
    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)
    9ms
    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)
    10ms
    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 SI-B001+SI-B003± Chemotherapy in the Treatment of Locally Advanced or Metastatic Non-small Cell Lung Cancer (clinicaltrials.gov)
    P1/2, N=160, Not yet recruiting, Sichuan Baili Pharmaceutical Co., Ltd.
    New P1/2 trial
    |
    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)
    |
    BRAF mutation • BRAF V600 • EGFR wild-type • MET exon 14 mutation • ALK fusion • RET mutation • ROS1 fusion • ROS1 rearrangement • RET rearrangement • NTRK fusion
    |
    izalontamab (SI-B001) • danvilostomig (SI-B003)
    10ms
    A Study of SI-B003, a PD-1/CTLA-4 Bispecific Antibody, in Patients With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=159, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Trial completion date: May 2023 --> Sep 2023 | Trial primary completion date: May 2023 --> Sep 2023
    Trial completion date • Trial primary completion date • Metastases
    |
    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)
    1year
    SI-B003 (PD-1/CTLA-4) in patients with advanced solid tumors: A phase I study. (ASCO 2023)
    SI-B003 demonstrated a tolerable safety profile and preliminary anti-tumor activity in patients with recurrent or metastatic solid tumors. Anti-tumor effects of SI-B003 were observed in patients who had progressed on prior PD-1/L1 immunotherapy suggesting that SI-B003 may be beneficial for patients who have developed resistance to PD-1/L1 drugs. Clinical trial information: NCT04606472.
    Clinical • P1 data • Metastases
    |
    PD-1 (Programmed cell death 1) • CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4)
    |
    danvilostomig (SI-B003)
    1year
    Clinical Study of SI-B001+SI-B003± Chemotherapy in Patients With Locally Advanced or Metastatic Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov)
    P1/2, N=40, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    izalontamab (SI-B001) • danvilostomig (SI-B003)
    over1year
    Clinical Study of SI-B001+SI-B003± Chemotherapy in Patients With Locally Advanced or Metastatic Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov)
    P1/2, N=40, Not yet recruiting, Sichuan Baili Pharmaceutical Co., Ltd.
    New P1/2 trial • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    izalontamab (SI-B001) • danvilostomig (SI-B003)