eligibility_summary
Eligibility: ECOG 0–1, unresectable metastatic CRC with measurable disease, no BRAF V600E and not dMMR/MSI‑H. Stage 2: submit tumor for AbbVie c‑Met IHC, if archival lacks c‑Met 3+ in ≥10% tumor cells, recent biopsy may be reassessed. Exclude: recent CHF/ischemia/arrhythmia/pericardial disease, prior c‑Met antibodies/ADCs, ILD/pneumonitis or serious lung disease, unresolved >G1 toxicities (except neutropenia≤G2, neuropathy≤G2, alopecia), untreated CNS mets, other cancers <5y (low risk excepted).
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
- Intervention: Telisotuzumab adizutecan (ABBV-400), an intravenous antibody–drug conjugate (ADC). It consists of a humanized anti–c-Met (MET/HGFR) monoclonal antibody linked via a cleavable linker to a topoisomerase I–inhibitor (“-tecan,” DXd-like) payload. - Mechanism of action: The antibody binds c-Met on tumor cells, is internalized, and releases the topo-I inhibitor intracellularly to induce DNA damage and cell death, the membrane-permeable payload may enable bystander killing of adjacent tumor cells. - Cells/pathways targeted: c-Met–overexpressing colorectal cancer cells, the HGF/MET receptor tyrosine kinase pathway and its downstream signaling (e.g., PI3K/AKT and RAS/MAPK) that drive proliferation, survival, and invasion, and DNA replication via topoisomerase I inhibition. - Study design: Phase 1b dose-escalation/expansion in Chinese adults with unresectable/metastatic CRC, expansion enriches for high c-Met expression (IHC 3+, ≥10%).