Spots Global Cancer Trial Database for A Study of FX-909 in Patients With Advanced Solid Malignancies, Including Advanced Urothelial Carcinoma
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Trial Identification
Brief Title: A Study of FX-909 in Patients With Advanced Solid Malignancies, Including Advanced Urothelial Carcinoma
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
Study ID: NCT05929235
Interventions
Study Description
Brief 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
Detailed 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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
HonorHealth, Scottsdale, Arizona, United States
Yale Cancer Center, New Haven, Connecticut, United States
Mass General Cancer Center, Boston, Massachusetts, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
Icahn School of Medicine at Mount Sinai, New York, New York, United States
Memorial Slone Kettering Cancer Center, New York, New York, United States
UNC Lineberger Comprehensive Cancer Center, Chapel Hill, North Carolina, United States
The Cleveland Clinic Foundation, Cleveland, Ohio, United States
Sarah Cannon Research Institute, Nashville, Tennessee, United States
New Experimental Therapeutics of San Antonio (NEXT), San Antonio, Texas, United States
South Texas Accelerated Research Therapeutics (START), San Antonio, Texas, United States
Contact Details
Name: Gopa Iyer, MD
Affiliation: Memorial Slone Kettering
Role: PRINCIPAL_INVESTIGATOR
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