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A Study of FX-909 in Patients With Advanced Solid Malignancies, Including Advanced Urothelial Carcinoma

NCT05929235 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-04-20

No results posted yet for this study

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.

Conditions

  • Advanced Urothelial Carcinoma
  • Oral Drug Administration
  • Open Label

Interventions

DRUG

FX-909

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

DRUG

Pembrolizumab (KEYTRUDA ®)

Pembrolizumab is an immunotherapy checkpoint inhibitor.

DRUG

KEYTRUDA ®( Pembrolizumab)

Keytruda is an immunotherapy checkpoint inhibitor.

Sponsors & Collaborators

Principal Investigators

  • Gopa Iyer, MD · Memorial Slone Kettering

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-24
Primary Completion
2027-10-30
Completion
2028-01-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05929235 on ClinicalTrials.gov