A Study of FX-909 in Patients With Advanced Solid Malignancies, Including Advanced Urothelial Carcinoma

The goal of this clinical trial is to study the safety and tolerability in all advanced solid tumors, including advanced urothelial carcinoma. The main question\[s\] it aims to answer are: * Is FX-909 safe and tolerable, as a monotherapy and in combination with Pembrolizumab * What is the right dose level for patients Participants will be asked to take FX-909 daily in tablet form, or FX-909 daily and Pembrolizumab every 3 weeks, and record any outcomes from taking the drug. Participants will also be asked to return for multiple site visits for various blood tests and to collect blood and tumor samples as well as have regular CT/MRI scans.

NCT Number	NCT05929235
Lead Sponsor	Flare Therapeutics Inc. Collaborators: Merck Sharp & Dohme LLC
Conditions	Advanced Urothelial Carcinoma, Oral Drug Administration, Open Label
Enrollment	120 participants
Start Date	2023-08-24
Primary Completion	2027-10-30 (estimated)
Study Completion	2028-01-30 (estimated)
Updated on ClinicalTrials.gov	2026-08-12