A Study of FX-909 in Patients With Advanced Solid Malignancies, Including Advanced Urothelial Carcinoma (NCT05929235)
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
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: UCSF Helen Diller Family Comprehensive Cancer Center — San Francisco, California
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (12 Sites)
- UCSF Helen Diller Family Comprehensive Cancer Center — San Francisco, California
- Yale Cancer Center — New Haven, Connecticut
- Sylvester Comprehensive Cancer Center, University of Miami — Miami, Florida
- The University of Chicago Medicine — Chicago, Illinois
- Mass General Cancer Center — Boston, Massachusetts
- Dana Farber Cancer Institute — Boston, Massachusetts
- Icahn School of Medicine at Mount Sinai — New York, New York
- Memorial Slone Kettering Cancer Center — New York, New York
- UNC Lineberger Comprehensive Cancer Center — Chapel Hill, North Carolina
- The Cleveland Clinic Foundation — Cleveland, Ohio
- Sarah Cannon Research Institute — Nashville, Tennessee
- Houston Methodist Cockrell Center for Advanced Therapeutics — Houston, Texas
📞 Contact the Study Coordinator
Phone: (877) 827-3222
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Advanced Urothelial Carcinoma
- A Study to Evaluate Safety, Efficacy of FF-10832 in Combo With Pembrolizumab in Urothelial & Non-small Cell Lung Cancer — Long Beach, California
- Eribulin Mesylate in Treating Patients With Locally Advanced or Metastatic Cancer of the Urothelium and Kidney Dysfunction — Beverly Hills, California
- Immunotherapy Plus Capivasertib for Metastatic Bladder Cancer — West Haven, Connecticut
Explore by condition: All Advanced Urothelial Carcinoma clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.