NCT05929235

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

A Phase 1, First-in-Human, Dose-Escalation and Expansion Study of FX-909 (as Monotherapy or in Combination With Pembrolizumab) in Patients With Advanced Solid Malignancies, Including Advanced Urothelial Carcinoma

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Flare Therapeutics Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is an open-label Phase 1 study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary clinical activity of FX-909 given orally (PO) in patients with advanced solid malignancies. Initially, FX-909 will be given in a dose-escalation phase (Part A) to determine the preliminary recommended phase 2 dose (RP2D). Part B will be a dose expansion phase to further evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and clinical activity of FX-909 in patients with locally advanced (unresectable) and metastatic urothelial carcinoma. Part 1A1 will be a dose escalation of FX-909 in combination with Pembrolizumab. Throughout the study patients will be treated in 28 or 21-day cycles.

Conditions

• Advanced Urothelial Carcinoma
• Oral Drug Administration
• Open Label

Interventions

Type	Name	Description
DRUG	FX-909	FX-909 is an orally available new molecular entity that inhibits basal- and ligand-activated transcription by PPARG.
DRUG	Pembrolizumab (KEYTRUDA ®)	Pembrolizumab is an immunotherapy checkpoint inhibitor.
DRUG	KEYTRUDA ®( Pembrolizumab)	Keytruda is an immunotherapy checkpoint inhibitor.

Timeline

• Start date: 2023-08-24
• Primary completion: 2027-10-30
• Completion: 2028-01-30
• First posted: 2023-07-03
• Last updated: 2026-01-30

Locations

11 sites across 1 country: United States

Regulatory

• FDA-regulated drug study