^
    3d
    Targeting tumor microenvironment-derived NRG1-HER2/3 signaling with zenocutuzumab restores sensitivity to AR inhibition in PTEN wild-type prostate cancer. (PubMed, Mol Cancer Ther)
    In the context of PTEN loss and AR inhibitor resistance, zenocutuzumab did not restore sensitivity. These findings highlight the critical molecular context in which tumor microenvironment (TME)-derived NRG1 impacts responsiveness to AR inhibition and suggest that targeting NRG1 is a promising strategy for overcoming resistance to androgen blockade in PTEN-wildtype prostate cancers.
    Journal
    |
    HER-2 (Human epidermal growth factor receptor 2) • PTEN (Phosphatase and tensin homolog) • ERBB3 (V-erb-b2 avian erythroblastic leukemia viral oncogene homolog 3) • NRG1 (Neuregulin 1)
    |
    Bizengri (zenocutuzumab-zbco)
    10d
    Phase 1 trial of a novel antibody-targeted radiotherapy in patients with metastatic castrate-resistant prostate cancer (mCRPC) (ACTRN12625001362482)
    P1, N=42, Not yet recruiting, Actinium Pharmaceuticals Australia Pty Limited
    New P1 trial
    |
    ERBB3 (V-erb-b2 avian erythroblastic leukemia viral oncogene homolog 3)
    |
    ERBB3 positive
    |
    barecetamab (ISU104)
    2ms
    RENEU-PH: Study of JK07 in Patients With Heart Failure and WHO Group 2 Combined Post- and Pre-Capillary Pulmonary Hypertension (clinicaltrials.gov)
    P2, N=30, Not yet recruiting, Salubris Biotherapeutics Inc
    New P2 trial
    3ms
    A 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=130, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Trial completion date: Dec 2025 --> Dec 2027 | Trial primary completion date: Dec 2025 --> Dec 2026
    Trial completion date • Trial primary completion date
    |
    PD-L1 (Programmed death ligand 1)
    |
    izalontamab (SI-B001) • danvilostomig (SI-B003)
    3ms
    A Clinical Study of SI-B001 in Combination With Paclitaxel in the Treatment of Recurrent and Metastatic HNSCC (clinicaltrials.gov)
    P2, N=42, Active, not recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Recruiting --> Active, not recruiting | N=30 --> 42
    Enrollment closed • Enrollment change
    |
    paclitaxel • izalontamab (SI-B001)
    3ms
    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. | Trial completion date: Nov 2025 --> Dec 2027 | Trial primary completion date: Nov 2025 --> Dec 2026
    Trial completion date • Trial primary completion date
    |
    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)
    3ms
    SI-B001 Combined With Chemotherapy in the Treatment of EGFR/ALK WT Recurrent or Metastatic NSCLC. (clinicaltrials.gov)
    P2, N=69, Active, not recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase)
    |
    EGFR wild-type • ALK wild-type
    |
    cisplatin • paclitaxel • docetaxel • pemetrexed • 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, Active, not recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    izalontamab (SI-B001)
    3ms
    SI-B001 Combined With Irinotecan in the Treatment of Recurrent Metastatic Esophageal Squamous Cell Carcinoma. (clinicaltrials.gov)
    P2, N=22, Active, not recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Recruiting --> Active, not recruiting | N=40 --> 22
    Enrollment closed • Enrollment change
    |
    irinotecan • izalontamab (SI-B001)
    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=11, Active, not recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Recruiting --> Active, not recruiting | N=30 --> 11
    Enrollment closed • Enrollment change
    |
    izalontamab (SI-B001)
    3ms
    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
    Enrollment closed
    |
    EGFR mutation
    |
    Tagrisso (osimertinib) • 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: Jun 2025 --> Dec 2025 | Trial primary completion date: Jun 2025 --> Dec 2025
    Trial completion date • Trial primary completion date
    |
    irinotecan • izalontamab (SI-B001)