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

Advanced Urothelial Carcinoma Clinical Trial

Official title:
A Phase 1, First-in-Human, Dose-Escalation and Expansion Study of FX-909 in Patients With Advanced Solid Malignancies, Including Advanced Urothelial Carcinoma

Clinical Trial 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 - What is the right dose level for patients Participants will be asked to take FX-909 daily , in tablet form 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

Clinical Trial 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 monotherapy 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. Throughout the study patients will be treated in 28-day cycles. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05929235
Study type Interventional
Source Flare Therapeutics Inc.
Contact Melissa Moles, VP Clinical Operations
Phone 6173722515
Email clinops@flaretx.com
Status Recruiting
Phase Phase 1
Start date September 13, 2023
Completion date January 30, 2027
View Details
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