Summary
This is a Phase 1/2, open-label, FIH study designed to evaluate the safety, tolerability,
pharmacokinetics (PK), pharmacodynamics (PDy), and antineoplastic activity of RLY-4008, a
potent and highly selective FGFR2 inhibitor, in patients with unresectable or metastatic
cholangiocarcinoma (CCA) and other solid tumors. The study consists of 4 parts: a dose
escalation (Part 1), a dose expansion (Part 2), and an extension (Part 3) and a rollover
(Part 4).