RecruitingPhase 1NCT05929235

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


Sponsor

Flare Therapeutics Inc.

Enrollment

120 participants

Start Date

Aug 24, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called FX-909, a drug called KEYTRUDA ®( Pembrolizumab), and others for people with advanced urothelial carcinoma, open label, and other related conditions. The study is currently recruiting participants at 12 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGFX-909

FX-909 is an orally available new molecular entity that inhibits basal- and ligand-activated transcription by PPARG.

DRUGPembrolizumab (KEYTRUDA ®)

Pembrolizumab is an immunotherapy checkpoint inhibitor.

DRUGKEYTRUDA ®( Pembrolizumab)

Keytruda is an immunotherapy checkpoint inhibitor.


Locations(12)

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, United States

Yale Cancer Center

New Haven, Connecticut, United States

Sylvester Comprehensive Cancer Center, University of Miami

Miami, Florida, United States

The University of Chicago Medicine

Chicago, Illinois, United States

Mass General Cancer Center

Boston, Massachusetts, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Memorial Slone Kettering Cancer Center

New York, New York, United States

UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, United States

The Cleveland Clinic Foundation

Cleveland, Ohio, United States

Sarah Cannon Research Institute

Nashville, Tennessee, United States

Houston Methodist Cockrell Center for Advanced Therapeutics

Houston, Texas, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05929235


Related Trials