OncoMatch/Clinical Trials/NCT05882292
c-MET Inhibitor in Advanced Solid Tumors With c-MET Gene Aberration
Is NCT05882292 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies ABN401 for neoplasms.
Treatment: ABN401 — c-MET is a member of the receptor tyrosine kinase (RTK) family. Essential components of signal transduction pathways regulating processes including cell proliferation, differentiation, migration, metabolism, and cell cycle control, RTKs are established targets as treatment strategies for various cancers. c-MET is expressed mainly in epithelial tissues and is subject to dysregulation manifesting as mutations, amplifications, and overexpression. c-MET is implicated in both primary oncogenesis, metastasis and also as a mechanism of drug resistance. c-MET has a high affinity for its naturally occurring ligand, Hepatocyte Growth Factor (HGF, also known as Scatter Factor). Binding of HGF to c-MET induces several complex signaling pathways, resulting in cell proliferation, survival, motility, induction of cells polarity, scattering, angiogenesis, and invasion. c-MET alterations are identified in various cancers. Several drugs targeting c-MET inhibition have been developed, and capmatinib was approved by FDA in patients with non-small cell lung cancer harboring MET exon 14 skipping mutation. ABN401 competitively attaches to the ATP binding sites in the kinase domain of c-MET with high specificity to inhibit phosphorylation of downstream signaling pathways. Following several animal studies of advanced solid cancers, the first-in-human trial of ABN401 showed anti-tumor activity without DLT, and the phase 2 trial is ongoing. Recently, the basket trials have been emphasized for tissue agnostic approach targeting certain genetic alterations, and the NCI-MATCH (National Cancer Institute-MATCH) trials in 3,000 patients with advanced solid cancers are ongoing. Similarly, the KOSMOS-II study is ongoing in Korea. This study is the basket trial that Next-generation sequencing (NGS)-based genetic alterations, which is confirmed in Molecular Tumor Board (MTB), provide the individual treatment approach.
Check if I qualifyExtracted eligibility criteria
Biomarker criteria
Required: MET amplification (GCN ≥6 by NGS) (GCN ≥6)
c-MET amplification GCN (gene copy no.) ≥6 by NGS
Required: MET amplification (MET/CEP7 ratio ≥2 by FISH/SISH) (MET/CEP7 ratio ≥2)
Fluorescence/Silver In situ hybridization (FISH/SISH) result of the MET/CEP7 ratio ≥2
Required: MET other MET alterations regarded to be actionable by the KOSMOS MTB
Other MET alterations that are regarded to be actionable by the KOSMOS MTB
Excluded: MET exon 14 skipping mutation
exon 14 skipping mutation except for non-small cell lung cancer (NSCLC); NSCLC with c-MET exon 14 skipping mutation [excluded]
Disease stage
Metastatic disease required
At least one measurable or evaluable lesion based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: standard therapy
Disease progression during or after standard therapy and without further treatment options, or no standard therapy, or ineligible for standard therapy
Cannot have received: c-MET inhibitor
Previous treatment with c-MET inhibitor
Cannot have received: chemotherapy (mitomycin)
Chemotherapy or biologic agents within 3 weeks before study (targeted therapy within 2 weeks and mitomycin within 5 weeks)
Cannot have received: biologic agent
Chemotherapy or biologic agents within 3 weeks before study (targeted therapy within 2 weeks and mitomycin within 5 weeks)
Cannot have received: targeted therapy
targeted therapy within 2 weeks
Cannot have received: radiotherapy
Radiotherapy within 4 weeks before study or limited radiotherapy within 2 weeks
Cannot have received: major surgery
Major surgery within 4 weeks before study (must have complete recovery from surgical complications)
Lab requirements
Blood counts
ANC ≥1500/mm3 (excluding measurements obtained within 7 days after G-CSF); Platelet count ≥75000/mm3 (excluding measurements obtained within 7 days after transfusion); Hemoglobin value of ≥8.0 g/dL
Kidney function
Creatinine clearance (CrCl) of ≥50 mL/min (MDRD)
Liver function
AST/ALT ≤3×ULN; if liver function abnormalities are due to underlying liver metastasis, AST / ALT ≤5×ULN; Total serum bilirubin of ≤1.5×ULN
Adequate organ functions: ANC ≥1500/mm3; Platelet count ≥75000/mm3; Hemoglobin value of ≥8.0 g/dL; AST/ALT ≤3×ULN (≤5×ULN with liver mets); Total serum bilirubin ≤1.5×ULN; CrCl ≥50 mL/min
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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