The trial NCT06669117 is a first-in-human, open-label Phase I/II study of VERT-002 (PFL-002), an intravenous c-MET degrader, in adults with locally advanced or metastatic solid tumors harboring documented MET gene alterations (e.g., MET ex14 skip, activating MET kinase-domain mutations, or MET amplification). The primary objective is to evaluate safety, tolerability and to determine the maximum tolerated dose (MTD) and/or optimal biologically active dose (OBD). Eligible adults have tumors for which no standard therapy is available, or NSCLC Stage IIIB/C or IV, with measurable disease per RECIST 1.1 and ECOG performance status 0–1. MET alteration status is confirmed at screening via local or central testing. Participants receive VERT-002 in a sequential dose-escalation followed by expansion cohort. Key secondary endpoints include pharmacokinetics, objective response rate and safety profile.
This study investigates the investigational drug VERT-002 in adults with locally advanced or metastatic solid tumors harboring MET gene alterations. The aim is to evaluate safety, tolerability and to determine the optimal dosing regimen of VERT-002. Participants include adults for whom no standard treatment is available or adults with non-small cell lung cancer (NSCLC) Stage IIIB/C or IV. MET alterations are confirmed in tumor tissue or blood samples. All participants receive VERT-002 in a dose escalation and expansion design. Additional key outcomes include preliminary signs of activity and pharmacokinetics.
