A small-molecule inverse agonist of PPARγ for advanced solid tumors: a phase 1 trial.
Matthew D Galsky, Charlene Mantia, Michaela Bowden...
https://pubmed.ncbi.nlm.nih.gov/41760953Actively Recruiting
Phase 1
Age: 18Years +
All Genders
ID05929235
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
Led by Flare Therapeutics Inc. · Updated on 2026-04-20
120
Participants Needed
12
Research Sites
13 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
Researchers are evaluating the safety and tolerability of FX-909, given alone or combined with Pembrolizumab, in patients with advanced solid tumors including advanced urothelial carcinoma. This open-label Phase 1 study aims to find the right dose and gather early information on how the drugs behave in the body and their preliminary effects on the cancer. The study is sponsored by Flare Therapeutics Inc. and includes patients who have advanced or metastatic cancer that has progressed after available treatments. Participants will receive FX-909 orally as a daily tablet, either alone or with Pembrolizumab given every three weeks. The study has several parts: an initial dose-escalation phase to determine the recommended dose, a dose-expansion phase focusing on urothelial carcinoma with high PPARG protein expression, and a combination dose-escalation phase with Pembrolizumab. Treatments are administered in cycles lasting 21 or 28 days, depending on the study part. Throughout the study, participants will attend multiple visits for blood tests, collection of tumor and blood samples, and regular CT or MRI scans to monitor their health and cancer status. They will record any side effects or outcomes from the treatment. The main goal is to assess dose-limiting toxicities and adverse events over about three years. Researchers will also monitor drug behavior in the body and preliminary anti-tumor activity to better understand the treatment's effects.
CONDITIONS
Brief Title
A Study of FX-909 in Patients With Advanced Solid Malignancies, Including Advanced Urothelial Carcinoma
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Able to understand and willing to sign an informed consent.
- Age 18 years or older.
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2.
- Provide an archival tumor sample no more than 30 months old or agree to a fresh biopsy.
- For Part A: Diagnosed with locally advanced or metastatic solid malignancies progressed after standard therapy or with no standard therapy available.
- For Part B: Histologically confirmed advanced urothelial carcinoma with high PPARG protein expression (Tumor Positivity Score 60%).
- Treated with 4 or fewer prior therapies for advanced disease.
- Measurable disease per RECIST 1.1 criteria.
- Screening laboratory values meeting study requirements.
- For Part 1A1: ECOG 0 or 1, progressed after all standard therapies including anti-PD-1/L1 treatment.
- Adequate organ function as defined by study tables.
- For Part 1A1: Male participants agree to use contraception during the study and for 90 days after last dose.
- For Part 1A1: Female participants of childbearing potential must have negative pregnancy test and use effective contraception.
You will not qualify if you...
- Pregnant or breastfeeding females.
- Prior anticancer chemotherapy or targeted therapy within 2 weeks or 5 half-lives before study drug.
- Prior therapy inhibiting PPARG or RXRA.
- Unresolved adverse events from prior therapy above Grade 1 except specified exceptions.
- Major surgery within 4 weeks before study drug.
- Recent radiation therapy without adequate washout.
- History of other malignancies within 2 years except certain treated cancers.
- QTcF >470 msec or history of long QT syndrome.
- Active uncontrolled infections or immunodeficiency.
- History of pancreatitis within 6 months.
- Significant lung impairment or oxygen requirement.
- Active or symptomatic CNS metastases.
- Need for high-dose steroids or prohibited therapies.
- Participation in other investigational trials.
- Cardiovascular diseases within past 6 months.
- Thromboembolic events within 28 days before study drug.
- Severe hypersensitivity to study drugs.
- Gastrointestinal disorders interfering with medication intake.
- Immediate family member employed at study site or sponsor unless approved.
- Conditions potentially hampering compliance or safety evaluation.
- History of stem cell or organ transplant.
- Pregnant, breastfeeding, or planning conception during study period.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Repeated 21 or 28-day cycles until disease progression or discontinuation
Participants receive FX-909 orally, alone or in combination with Pembrolizumab, in repeated 21 or 28-day cycles to evaluate safety, tolerability, and preliminary clinical activity.
Regular visits each cycle for treatment and assessments
Follow-up
Duration - Up to approximately 3 years after treatment completion
Participants are monitored for safety and adverse events after treatment ends.
Periodic visits for safety monitoring
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
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Research Team
J
Janine Koucheki, Associate Director, Clinical Operations
C
Carolyn McCrone, Sr Clinical Trial Associate
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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