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

Summary

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.

Timeline

Start

2023-08-24

Primary completion

2027-10-30

Completion

2028-01-30

Publications

• Galsky MD, Mantia C, Bowden M, Bellmunt J, Garmezy B, Iyer G, Petrylak DP, Rasco D, Gupta S, Rodriguez-Rivera I, Mikhailov Y, Joshi A, Nguyen PA, Kakrecha B, Tepper J, Costa AM, McCrone C, Rossi AP, Mertz JA, Gjini E, Meyers ML, Milowsky MI, Gao X. A small-molecule inverse agonist of PPARgamma for advanced solid tumors: a phase 1 trial. Nat Med. 2026 Apr;32(4):1249-1256. doi: 10.1038/s41591-026-04263-3. Epub 2026 Feb 28.

Drugs

Indications