A First-in-Human Study of Highly Selective FGFR2 Inhibitor, RLY-4008, in Patients with intrahepatic Cholangiocarcinoma and Other Advanced Solid Tumors
This is a Phase 1/2, open-label, first-in-human study designed to evaluate the safety, tolerability, PK, PDy*, and antineoplastic activity** of RLY-4008, a potent and highly selective FGFR2 inhibitor, in patients with unresectable or metastatic CCA and other solid tumors. The study consists of 3 parts: a dose escalation (Part 1), a dose expansion (Part 2), and an extension (Part 3).
*PK and PDY = Pharmacokinetics (PK) represents “what the body does to the drug,” whereas pharmacodynamics (PD) can be defined as “what the drug does to the body,” or, more specifically, to target cell-types, tissues, or organs.
** antineoplastic activity = Blocking the formation of neoplasms (growths that may become cancer).
This trial is currently open and recruiting in the UK at the following sites:
Sarah Cannon Research Institute UK
London, W1G 6AD
University College London Hospitals NHS Foundation Trust
London, W1T 7HA
The Christie NHS Foundation Trust
Manchester, M20 4BX
For further information including eligibility criteria, and European and international sites, see: https://clinicaltrials.gov/ct2/show/NCT04526106
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