At a glance
ClinicalIndex Comparison Record- ✓Age ≥18 years
- ✓ECOG performance status 0, 1, or 2 (Part A/B) or 0-1 (Part 1A1)
- ✓Part A: Advanced/metastatic solid malignancies progressed after standard therapy or no standard therapy exists; ≤4 prior therapies
- ✓Part B: Urothelial carcinoma with PPARG TPS ≥60% by IHC; ≤4 prior therapies; progressed after standard therapy or unable to tolerate
- ✕Pregnant or breastfeeding
- ✕Prior PPARG or RXRA-inhibiting therapy
- ✕Unresolved Grade ≥2 adverse events from prior therapy (except alopecia, hearing loss, vitiligo, endocrinopathy with replacement, neuropathy ≤Grade 2)
- ✕Major surgery within 4 weeks
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 1 clinical trial evaluating FX-909, Pembrolizumab (KEYTRUDA ®), and 1 other intervention for Advanced Urothelial Carcinoma and 2 related conditions. Currently recruiting, targeting 120 participants across 12 sites.
Detailed 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.
Study Details
Timeline
Interventions
FX-909 is an orally available new molecular entity that inhibits basal- and ligand-activated transcription by PPARG.
Pembrolizumab is an immunotherapy checkpoint inhibitor.
Keytruda is an immunotherapy checkpoint inhibitor.