eligibility_summary
Include: 18–75, advanced/metastatic EGFR ex19del/L858R NSCLC, ECOG 0–1, ≥3‑mo survival, RECIST. P1: progressed/intolerant/refuse standard (befotertinib: progressed). P2 cohorts: A naive, B 3rd‑gen TKI‑R, C 1st/2nd‑gen TKI‑R, B/C also platinum‑R/intolerant/refuse. Exclude: recent trial Rx/surgery/RT, >3 prior lines, prior EGFR/MET bispecifics, unresolved >G1 tox, unstable CNS mets, CV/QTc issues, active HBV/HCV/HIV, ILD, serious GI, uncontrolled illness, pregnancy, strong CYP3A meds, allergy.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase I single-arm study testing: 1) MCLA-129—an IV anti‑EGFR/c‑MET bispecific monoclonal antibody that blocks ligand-driven EGFR and MET receptor signaling and can engage Fc‑mediated cytotoxicity (e.g., ADCC/ADCP), aiming to suppress parallel/bypass activation (including MET‑driven resistance) and downstream MAPK and PI3K–AKT pathways, 2) Befotertinib (D‑0316)—an oral, third‑generation, irreversible, mutant‑selective EGFR tyrosine kinase inhibitor that covalently inhibits EGFR activating mutations (Ex19del, L858R) and T790M while sparing wild‑type EGFR. Targets: EGFR‑mutated NSCLC cells, EGFR and MET receptor tyrosine kinases, downstream RAS–RAF–MEK–ERK and PI3K–AKT signaling, including MET‑amplification/bypass resistance pathways.