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    DRUG:

    izalontamab (SI-B001)

    i
    Other names: SI-B001
    Company:
    Biokin Pharma
    Drug class:
    EGFR inhibitor, HER3 inhibitor
    Related drugs:
    3ms
    A Clinical Study to Evaluate the Efficacy and Safety of SI-B001 in the Treatment of Recurrent and Metastatic HNSCC (clinicaltrials.gov)
    P2, N=30, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Trial completion date: Dec 2023 --> Apr 2024 | Trial primary completion date: Dec 2023 --> Apr 2024
    Trial completion date • Trial primary completion date • Metastases
    |
    izalontamab (SI-B001)
    3ms
    A Clinical Study of SI-B001 in Combination With Paclitaxel in the Treatment of Recurrent and Metastatic HNSCC (clinicaltrials.gov)
    P2, N=30, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Trial completion date: Dec 2023 --> Jun 2024 | Trial primary completion date: Dec 2023 --> Jun 2024
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    paclitaxel • izalontamab (SI-B001)
    3ms
    SI-B001 Combined With Chemotherapy in the Treatment of EGFR/ALK WT Recurrent or Metastatic NSCLC. (clinicaltrials.gov)
    P2, N=60, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Trial completion date: Dec 2023 --> Apr 2024 | Trial primary completion date: Dec 2023 --> Apr 2024
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase)
    |
    EGFR wild-type • ALK wild-type • EGFR wild-type + ALK wild-type
    |
    cisplatin • paclitaxel • docetaxel • pemetrexed • izalontamab (SI-B001)
    3ms
    SI-B001 Combined With Irinotecan in the Treatment of Recurrent Metastatic Esophageal Squamous Cell Carcinoma. (clinicaltrials.gov)
    P2, N=40, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Trial completion date: Dec 2023 --> Apr 2024 | Trial primary completion date: Dec 2023 --> Apr 2024
    Trial completion date • Trial primary completion date • Metastases
    |
    irinotecan • izalontamab (SI-B001)
    3ms
    A Study of SI-B001, an EGFR/HER3 Bispecific Antibody, in Locally Advanced or Metastatic Epithelial Tumors (clinicaltrials.gov)
    P1, N=60, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Trial completion date: Dec 2023 --> Apr 2024 | Trial primary completion date: Dec 2023 --> Apr 2024
    Trial completion date • Trial primary completion date • Metastases
    |
    izalontamab (SI-B001)
    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)
    6ms
    A Study of SI-B001, an EGFR/HER3 Bispecific Antibody, in Locally Advanced or Metastatic Epithelial Tumors (clinicaltrials.gov)
    P1, N=60, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Trial completion date: Aug 2023 --> Dec 2023 | Trial primary completion date: Aug 2023 --> Dec 2023
    Trial completion date • Trial primary completion date • Metastases
    |
    izalontamab (SI-B001)
    6ms
    A Clinical Study to Evaluate the Efficacy and Safety of SI-B001 in the Treatment of Recurrent and Metastatic HNSCC (clinicaltrials.gov)
    P2, N=30, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Trial completion date: Jul 2023 --> Dec 2023 | Trial primary completion date: Jul 2023 --> Dec 2023
    Trial completion date • Trial primary completion date • Metastases
    |
    izalontamab (SI-B001)
    6ms
    SI-B001 Combined With Irinotecan in the Treatment of Recurrent Metastatic Esophageal Squamous Cell Carcinoma. (clinicaltrials.gov)
    P2, N=40, 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
    |
    irinotecan • izalontamab (SI-B001)
    6ms
    A Clinical Study of SI-B001 in Combination With Paclitaxel in the Treatment of Recurrent and Metastatic HNSCC (clinicaltrials.gov)
    P2, N=30, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Trial completion date: Jul 2023 --> Dec 2023 | Trial primary completion date: Jul 2023 --> Dec 2023
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    paclitaxel • izalontamab (SI-B001)
    9ms
    A Clinical Study of SI-B001 Combined With Docetaxel in the Treatment of Non-small Cell Lung Adenocarcinoma and Lung Squamous Cell Carcinoma (clinicaltrials.gov)
    P3, N=584, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    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) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • NTRK (Neurotrophic receptor tyrosine kinase)
    |
    KRAS mutation • KRAS G12C • BRAF mutation • HER-2 amplification • BRAF V600 • KRAS G12D • EGFR wild-type • KRAS G12V • RET mutation • ALK wild-type • ROS1 fusion • ROS1 rearrangement • MET mutation • RET rearrangement • KRAS G12 • KRAS amplification • EGFR wild-type + ALK wild-type • NTRK fusion
    |
    docetaxel • izalontamab (SI-B001)
    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 Clinical Study of SI-B001 Combined With Docetaxel in the Treatment of Non-small Cell Lung Adenocarcinoma and Lung Squamous Cell Carcinoma (clinicaltrials.gov)
    P3, N=584, Not yet recruiting, Sichuan Baili Pharmaceutical Co., Ltd.
    New P3 trial
    |
    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) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • NTRK (Neurotrophic receptor tyrosine kinase)
    |
    KRAS mutation • KRAS G12C • BRAF mutation • HER-2 amplification • BRAF V600 • KRAS G12D • EGFR wild-type • KRAS G12V • RET mutation • ALK wild-type • ROS1 fusion • ROS1 rearrangement • MET mutation • RET rearrangement • KRAS G12 • KRAS amplification • EGFR wild-type + ALK wild-type • NTRK fusion
    |
    docetaxel • izalontamab (SI-B001)
    almost1year
    A Study of SI-B001, an EGFR/HER3 Bispecific Antibody, in Locally Advanced or Metastatic Epithelial Tumors (clinicaltrials.gov)
    P1, N=60, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Active, not recruiting --> Recruiting
    Enrollment open • Metastases
    |
    izalontamab (SI-B001)
    almost1year
    SI-B001 Combined With Osimertinib Mesylate Tablets in the Treatment of Recurrent Metastatic Non-small Cell Lung Cancer. (clinicaltrials.gov)
    P2/3, N=14, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Active, not recruiting --> Recruiting
    Enrollment open • Combination therapy • Metastases
    |
    EGFR mutation • EGFR T790M negative
    |
    Tagrisso (osimertinib) • izalontamab (SI-B001)
    1year
    SI-B001 plus chemotherapy in patients with locally advanced or metastatic EGFR/ALK wild-type non-small cell lung cancer: A phase II, multicenter, open-label study. (ASCO 2023)
    SI-B001 plus docetaxel demonstrated antitumor activity in locally advanced or metastatic NSCLC EGFR/ALK wild-type pts who failed on prior first-line anti-PD-1/L1 antibody plus PBC, especially without AGA. The toxicity of SI-B001 + docetaxel was manageable. These findings support the continued investigation of SI-B001 and docetaxel as a treatment option in NSCLC.
    Clinical • P2 data • Metastases
    |
    EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase)
    |
    EGFR wild-type • ALK wild-type
    |
    docetaxel • izalontamab (SI-B001)
    1year
    SI-B001 Combined With Osimertinib Mesylate Tablets in the Treatment of Recurrent Metastatic Non-small Cell Lung Cancer. (clinicaltrials.gov)
    P2/3, N=14, Active, not recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Recruiting --> Active, not recruiting | N=50 --> 14
    Enrollment closed • Enrollment change • Combination therapy • Metastases
    |
    EGFR mutation • EGFR T790M negative
    |
    Tagrisso (osimertinib) • izalontamab (SI-B001)
    1year
    Anti-tumor efficacy of SI-B001, a novel EGFR×HER3 bispecific antibody, against EGFR-driven epithelial tumors alone or in combination with paclitaxel and carboplatin (AACR 2023)
    In vitro, the inhibition of tumor cell growth by SI-B001 was stronger than cetuximab and duligotuzumab in FaDu (mRNA expression levels of EGFRhigh/HER3high/NRG1medium). Currently, 6 phase II clinical trials of SI-B001, either alone or in combination with chemotherapy, have been conducted in different epithelial carcinomas. These studies have shown a potential break-through activity in NSCLC and HNSCC with a very good safety profile.
    Clinical • Combination therapy
    |
    HER-2 (Human epidermal growth factor receptor 2) • NRG1 (Neuregulin 1)
    |
    ERBB3 expression
    |
    Erbitux (cetuximab) • carboplatin • paclitaxel • izalontamab (SI-B001)
    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
    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)
    1year
    SI-B001 as a Single Agent or in Combination With Chemotherapy in the Treatment of Digestive System Malignancies (clinicaltrials.gov)
    P2, N=7, Terminated, Sichuan Baili Pharmaceutical Co., Ltd. | N=120 --> 7 | Trial completion date: Sep 2023 --> Jun 2022 | Recruiting --> Terminated | Trial primary completion date: Sep 2023 --> Jun 2022; Company research strategy adjustment
    Enrollment change • Trial completion date • Trial termination • Trial primary completion date • Combination therapy • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • MSI (Microsatellite instability)
    |
    MSI-H/dMMR • HER-2 negative • KRAS wild-type • BRAF wild-type • RAS wild-type + BRAF wild-type
    |
    5-fluorouracil • oxaliplatin • irinotecan • leucovorin calcium • izalontamab (SI-B001)
    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)
    2years
    SI-B001 Combined With Chemotherapy in the Treatment of EGFR/ALK WT Recurrent or Metastatic NSCLC. (clinicaltrials.gov)
    P2, N=60, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Phase classification: P2/3 --> P2
    Phase classification • Combination therapy
    |
    EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase)
    |
    EGFR wild-type • ALK wild-type • EGFR wild-type + ALK wild-type
    |
    cisplatin • paclitaxel • docetaxel • pemetrexed • izalontamab (SI-B001)
    over2years
    SI-B001 as a Single Agent or in Combination With Chemotherapy in the Treatment of Digestive System Malignancies (clinicaltrials.gov)
    P2, N=120, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Not yet recruiting --> Recruiting
    Clinical • Enrollment open • Combination therapy
    |
    HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • MSI (Microsatellite instability)
    |
    MSI-H/dMMR • HER-2 negative • KRAS wild-type • BRAF wild-type
    |
    5-fluorouracil • irinotecan • leucovorin calcium • izalontamab (SI-B001)
    over2years
    SI-B001 Combined With Chemotherapy in the Treatment of EGFR/ALK WT Recurrent or Metastatic NSCLC. (clinicaltrials.gov)
    P2/3, N=60, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open • Combination therapy
    |
    EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase)
    |
    EGFR wild-type • ALK wild-type • EGFR wild-type + ALK wild-type
    |
    cisplatin • paclitaxel • docetaxel • pemetrexed • izalontamab (SI-B001)
    over2years
    Efficacy and Safety of SI-B001 as a Single Agent or in Combination With Chemotherapy in the Treatment of Digestive System Malignancies (clinicaltrials.gov)
    P2, N=120, Not yet recruiting, Sichuan Baili Pharmaceutical Co., Ltd.
    Clinical • New P2 trial • Combination therapy
    |
    HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • MSI (Microsatellite instability)
    |
    MSI-H/dMMR • HER-2 negative
    |
    5-fluorouracil • irinotecan • leucovorin calcium • izalontamab (SI-B001)
    over2years
    A Phase II/III Study of SI-B001 in Combination With Osimertinib in the Treatment of EGFR/ALK WT Recurrent and Metastatic NSCLC (clinicaltrials.gov)
    P2/3, N=60, Not yet recruiting, Sichuan Baili Pharmaceutical Co., Ltd.
    Clinical • New P2/3 trial • Combination therapy
    |
    EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase)
    |
    Tagrisso (osimertinib) • izalontamab (SI-B001)