A Study of FX-909 in Patients With Advanced Solid Malignancies, Including Advanced Urothelial Carcinoma
Recruiting now · Phase 1
Conditions studied: Advanced Urothelial Carcinoma, Oral Drug Administration, Open Label
In brief
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.
Key facts
- Study ID
- NCT05929235
- Run by
- Flare Therapeutics Inc.
- People needed
- 120
- Starts
- 2023-08-24
- Expected to finish
- 2028-01-30
- Last updated by the study team
- 2026-04-20
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- UCSF Helen Diller Family Comprehensive Cancer Center — San Francisco, California, United States (enrolling)
- Yale Cancer Center — New Haven, Connecticut, United States (enrolling)
- Sylvester Comprehensive Cancer Center, University of Miami — Miami, Florida, United States (enrolling)
- The University of Chicago Medicine — Chicago, Illinois, United States (enrolling)
- Mass General Cancer Center — Boston, Massachusetts, United States (enrolling)
- Dana Farber Cancer Institute — Boston, Massachusetts, United States (enrolling)
- Icahn School of Medicine at Mount Sinai — New York, New York, United States (enrolling)
- Memorial Slone Kettering Cancer Center — New York, New York, United States (enrolling)
- UNC Lineberger Comprehensive Cancer Center — Chapel Hill, North Carolina, United States (enrolling)
- The Cleveland Clinic Foundation — Cleveland, Ohio, United States (enrolling)
- Sarah Cannon Research Institute — Nashville, Tennessee, United States (enrolling)
- Houston Methodist Cockrell Center for Advanced Therapeutics — Houston, Texas, United States (enrolling)
Full record on ClinicalTrials.gov
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