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    DRUG:

    bozitinib (APL-101)

    i
    Other names: CBT 101, CBT-101, APL101, APL-101, PLB-1001, CBI-3103, PLB1001
    Company:
    Apollomics, Avistone Biotech, LaunXP Biomedical
    Drug class:
    c-MET inhibitor
    Related drugs:
    4d
    An Open-Label, Single-Center, Multi-Cohort, Phase II Study Evaluating the Safety and Efficacy of Vebreltinib-Based Combination Therapy in Previously Treated Patients with Locally Advanced or Metastatic MET-Overexpressing Non-Small Cell Lung Cancer (ChiCTR2500112942)
    P2, N=52, Not yet recruiting, West China Hospital of Sichuan University; West China Hospital of Sichuan University
    New P2 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) • MET (MET proto-oncogene, receptor tyrosine kinase) • RET (Ret Proto-Oncogene) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • NTRK (Neurotrophic receptor tyrosine kinase)
    |
    BRAF V600E • KRAS mutation • EGFR mutation • BRAF V600 • ALK rearrangement • MET exon 14 mutation • MET overexpression • ALK fusion • RET mutation • ROS1 fusion • ROS1 rearrangement • MET mutation • MET expression • RET rearrangement • NTRK fusion
    |
    docetaxel • Jiataile (sacituzumab tirumotecan) • bozitinib (APL-101)
    14d
    A Study of PLB1001 Enteric Capsules in the Treatment of sGBM/IDH Mutant Glioblastoma Patients With the ZM Fusion Gene (FUGEN). (clinicaltrials.gov)
    P2/3, N=84, Active, not recruiting, Beijing Pearl Biotechnology Limited Liability Company | Trial completion date: Dec 2024 --> Dec 2026
    Trial completion date
    |
    cisplatin • temozolomide • etoposide IV • bozitinib (APL-101)
    14d
    Safety and Efficacy of Combining APL-101 With Frontline Osimertinib in Patients With EGFR-mutated Metastatic Non-small Cell Lung Cancer (NSCLC) (clinicaltrials.gov)
    P1/2, N=27, Active, not recruiting, Washington University School of Medicine | Recruiting --> Active, not recruiting | Trial completion date: May 2030 --> Dec 2029 | Trial primary completion date: Jun 2027 --> Jan 2027
    Enrollment closed • Trial completion date • Trial primary completion date
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation
    |
    Tagrisso (osimertinib) • bozitinib (APL-101) • simmitinib (SYHA1817)
    2ms
    Vebreltinib in MET amplification-driven advanced non-small-cell lung cancer (KUNPENG): a single-arm, multi-cohort, multicentre, phase 2 study. (PubMed, Lancet Oncol)
    Vebreltinib showed antitumour activity in patients with MET amplification-driven advanced NSCLC who had previously received chemotherapy or were chemotherapy-naive. Further research is needed to validate these findings.
    P2 data • Journal
    |
    MET (MET proto-oncogene, receptor tyrosine kinase)
    |
    MET amplification
    |
    bozitinib (APL-101)
    3ms
    A Concise Review of the Approved MET TKIs (Savolitinib, Gumarontinib, Vebreltinib, Tepotinib, Capmatinib) in China for MET Exon 14 Splice Site Mutated (METex14+) NSCLC Circa 2025. (PubMed, Lung Cancer (Auckl))
    Splice site mutations around or within exon 14 of MET (METex14+) are rare, but are one of the common actionable driver mutations in elderly patients with non-small cell lung cancer (NSCLC). On June 30, 2025, vebreltinib has been approved for NSCLC with MET amplification while combination of savoltinib and osimertinib has been approved for EGFR+ post EGFR TKINSCLC with MET amplification post EGFR TKI based on the SACHI trial (NCT05015608). We discuss the current unmet clinical need (need to develop Type II MET TKI to overcome acquired resistance MET mutations at D1228 and Y1230) and future optimal treatment approaches.
    Review • Journal
    |
    MET (MET proto-oncogene, receptor tyrosine kinase)
    |
    MET amplification • MET exon 14 mutation • MET mutation
    |
    Tagrisso (osimertinib) • Orpathys (savolitinib) • Tepmetko (tepotinib) • Tabrecta (capmatinib) • Haiyitan (gumarontinib) • bozitinib (APL-101)
    3ms
    A Dose Escalation Study of Vebreltinib Combined with Gamma Knife and Osimertinib in Non-Small Cell Lung Cancer Patients with New Intracranial Metastases or Progression of Original Intracranial Metastatic Lesions Accompanied by MET Abnormalities in Intracranial Lesions During Osimertinib Treatment (ChiCTR2500108242)
    P=N/A, N=9, Not yet recruiting, Beijing Tiantan Hospital Affiliated to Capital Medical University; Beijing Tiantan Hospital Affiliated to Capital Medical University
    New trial
    |
    MET (MET proto-oncogene, receptor tyrosine kinase)
    |
    MET amplification • MET exon 14 mutation • MET overexpression • MET mutation
    |
    Tagrisso (osimertinib) • bozitinib (APL-101)
    3ms
    A Open-Label, Randomized Controlled, Exploratory Clinical Study of Vebreltinib Combined with Temozolomide and Bevacizumab in Patients with Recurrent/Progressive Malignant Gliomas without MET Abnormalities (ChiCTR2500107448)
    P=N/A, N=64, Not yet recruiting, Beijing Tiantan Hospital, Capital Medical University; Beijing Tiantan Hospital, Capital Medical University
    New trial
    |
    MET (MET proto-oncogene, receptor tyrosine kinase)
    |
    MET amplification • MET overexpression • MET mutation
    |
    Avastin (bevacizumab) • temozolomide • bozitinib (APL-101)
    5ms
    Vebreltinib for Neoadjuvant in METex 14 Skipping Mutant Stage IIA-IIIB (N2) Non-small Cell Lung Cancer (NSCLC) (clinicaltrials.gov)
    P2, N=30, Not yet recruiting, Fudan University
    New P2 trial
    |
    bozitinib (APL-101)
    5ms
    Vebreltinib for Advanced or Metastatic CCS (clinicaltrials.gov)
    P2, N=30, Recruiting, Second Affiliated Hospital, School of Medicine, Zhejiang University
    New P2 trial
    |
    bozitinib (APL-101)
    5ms
    Bozitinib Combined With Chemotherapy as Radical Treatment for Stage IIA-IIIC MET-Altered Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P2, N=34, Not yet recruiting, Shanghai Pulmonary Hospital, Shanghai, China
    New P2 trial
    |
    bozitinib (APL-101)
    6ms
    Efficacy and safety of Vebreltinib combined with bevacizumab for metastatic non-squamous non-small cell lung cancer harboring MET exon 14 skipping mutations : A single-arm, single-center, phase Ⅱ study (ChiCTR2500104259)
    P2, N=30, Not yet recruiting, The First Affiliated Hospital of Zhengzhou University; The First Affiliated Hospital of Zhengzhou University
    New P2 trial
    |
    MET (MET proto-oncogene, receptor tyrosine kinase)
    |
    MET exon 14 mutation
    |
    Avastin (bevacizumab) • bozitinib (APL-101)