Actively Recruiting
A Study of FX-909 in Patients With Advanced Solid Malignancies, Including Advanced Urothelial Carcinoma
Led by Flare Therapeutics Inc. · Updated on 2026-04-20
120
Participants Needed
12
Research Sites
231 weeks
Total Duration
On this page
Sponsors
F
Flare Therapeutics Inc.
Lead Sponsor
M
Merck Sharp & Dohme LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of FX-909 in Patients With Advanced Solid Malignancies, Including Advanced Urothelial Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and willing to sign an informed consent.
- Age 18 years or older.
- ECOG performance status 0, 1, or 2.
- Provide an archival tumor sample no older than 30 months or consent to a fresh biopsy.
- Part A: Diagnosed with locally advanced or metastatic solid tumors that progressed after or lack standard therapy.
- Part B: Diagnosed with locally advanced or metastatic urothelial carcinoma with high PPARG expression (TPS 60%).
- Treated with 4 or fewer prior therapies for advanced or metastatic disease.
- Part A: Patients with or without measurable disease.
- Part B: Patients with measurable disease per RECIST 1.1 not previously irradiated or progressed after radiation.
- Meet required screening laboratory values.
- For Part 1A1: ECOG 0 or 1, progressed after standard therapies including anti-PD-1/L1 treatment.
- Provide archival or fresh tumor biopsy within 30 months.
- Recovery from prior anticancer therapy adverse events to Grade 1 or baseline.
- Males agree to use contraception during and 90 days after treatment.
- Females of childbearing potential have negative pregnancy test and use contraception during and 120 days after treatment.
- HIV-infected patients must have well-controlled HIV on ART.
- Patients with controlled HBV or cured HCV infection.
- Adequate organ function as defined in study tables.
You will not qualify if you...
- Pregnant or breastfeeding females.
- Recent anticancer therapy within 2 weeks or 5 half-lives before study drug.
- Prior therapy inhibiting PPARG or RXRA.
- Unresolved adverse events from prior therapies above Grade 1.
- Major surgery within 4 weeks before study drug.
- Recent radiation therapy without adequate washout.
- History of other malignancies within 2 years unless cured.
- QTcF > 470 msec or history of long QT syndrome.
- Active lipodystrophy/lipoatrophy or medications causing it.
- Active infections requiring treatment.
- Known HIV positive without viral suppression.
- Active hepatitis B or C infection without control.
- Recent pancreatitis or significant lung impairment.
- Uncontrolled CNS metastases or leptomeningeal disease.
- Need for high dose steroids or prohibited therapies.
- Participation in other investigational studies.
- Serious cardiovascular diseases or events within 6 months.
- Recent thromboembolic or bleeding disorders.
- Severe hypersensitivity to study drugs.
- Gastrointestinal disorders affecting drug intake.
- Family members involved in study staff unless approved.
- Conditions hampering study compliance or safety.
- Type 1 diabetes or uncontrolled type 2 diabetes requiring insulin.
- Psychological or social conditions interfering with participation.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 12 locations
1
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94158
Actively Recruiting
2
Yale Cancer Center
New Haven, Connecticut, United States, 06519
Actively Recruiting
3
Sylvester Comprehensive Cancer Center, University of Miami
Miami, Florida, United States, 33136
Actively Recruiting
4
The University of Chicago Medicine
Chicago, Illinois, United States, 60637
Actively Recruiting
5
Mass General Cancer Center
Boston, Massachusetts, United States, 02114
Actively Recruiting
6
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
7
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Actively Recruiting
8
Memorial Slone Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
9
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States, 27514
Actively Recruiting
10
The Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Actively Recruiting
11
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
Actively Recruiting
12
Houston Methodist Cockrell Center for Advanced Therapeutics
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
J
Janine Koucheki, Associate Director, Clinical Operations
CONTACT
C
Carolyn McCrone, Sr Clinical Trial Associate
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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