Phase 1/2 ALK201 FGFR2b-targeting ADC (TOP1 inhibitor payload) in advanced solid tumors

This first-in-human, open-label Phase 1/2 trial evaluates ALK201 monotherapy in adults with advanced/metastatic solid tumors, using sequential dose escalation (to define dose-limiting toxicities, maximum tolerated dose, and recommended Phase 2 dose) followed by dose expansion in selected tumor types. ALK201 is an antibody-drug conjugate from Shanghai Allink Biotherapeutics that targets FGFR2b and delivers a topoisomerase I inhibitor payload (exatecan-class), aiming to concentrate cytotoxic exposure in FGFR2b-expressing tumors while limiting systemic toxicity. The study measures safety/tolerability, pharmacokinetics, immunogenicity, and preliminary antitumor activity (including objective response rate and durability). FGFR2b overexpression is particularly enriched in gastric/GEJ cancer and is also seen in subsets of other epithelial tumors; the trial also plans biomarker analyses relating outcomes to FGFR2 alterations. Clinically, patients with metastatic gastric/GEJ cancer are typically treated with fluoropyrimidine/platinum-based chemotherapy plus HER2 therapy when HER2-positive, plus PD-1–based immunotherapy when appropriate, followed by later-line agents (for example, taxanes/irinotecan and targeted options such as CLDN18.2 therapy when eligible); this program probes whether FGFR2b-targeted ADC delivery can open a new targeted line for FGFR2b-high disease.