Phase 1/2a CKD-703 trial tests c-Met–targeting MMAE microtubule-inhibitor ADC in solid tumors/NSCLC.

This first-in-human, multicenter, open-label Phase 1/2a study evaluates CKD-703, an antibody-drug conjugate from Chong Kun Dang Pharmaceutical (CKD Pharm) that uses a c-Met–binding monoclonal antibody to deliver monomethyl auristatin E (MMAE), a microtubule inhibitor payload that induces mitotic arrest and tumor cell death after internalization. The trial uses sequential, non-randomized assignment across three parts: Part 1 dose escalation in advanced solid tumors (including NSCLC) with no remaining effective options; Part 2 expansion in c-Met–overexpressing nonsquamous NSCLC after at least 1 prior line; and Part 3 expansion in c-Met–expressing advanced solid tumors after standard therapy failure or intolerance. A key eligibility nuance is that NSCLC patients with other actionable driver alterations must have progressed on at least one approved targeted therapy, positioning CKD-703 for a biomarker-selected, post-standard setting. Today’s care for metastatic NSCLC is driver-directed TKIs when present, otherwise first-line platinum doublet chemotherapy plus PD-1/PD-L1 immunotherapy (then docetaxel- or ADC-based options later), and this study asks whether c-Met–directed payload delivery can produce responses in MET-amplified and/or c-Met–overexpressing disease where small-molecule MET inhibitors are most validated in MET exon 14–skipping, not overexpression alone.