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
Flare Therapeutics Inc.
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.
Description
This is an open-label Phase 1 study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary clinical activity of FX-909 given orally (PO) in patients with advanced solid malignancies. Initially, FX-909 will be given in a dose-escalation phase (Part A) to determine the preliminary recommended phase 2 dose (RP2D). Part B will be a dose expansion phase to further evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and clinical activity of FX-909 in patients with locally advanced (unresectable) and metastatic urothelial carcinoma. Part 1A1 will…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Part A/B Inclusion Criteria: 1. Able to understand and willing to sign an informed consent. 2. Age ≥ 18 years. 3. Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2. 4. An archival, paraffin-embedded, formalin-fixed, tumor sample (see Laboratory Manual for details) that in Part A is no more than 30 months old at the time of screening or in Part B is no more than 30 months old at time of pre-screening. If an archival tumor sample is not available or is older than 30 months, then the patient must consent to provide a fresh biopsy during screening. 5. Part A: Histologically…
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 CenterSan Francisco, California
- Yale Cancer CenterNew Haven, Connecticut
- Sylvester Comprehensive Cancer Center, University of MiamiMiami, Florida
- The University of Chicago MedicineChicago, Illinois
- Mass General Cancer CenterBoston, Massachusetts
- Dana Farber Cancer InstituteBoston, Massachusetts