Safety and Anti-Tumor Activity of TYRA-200 in Advanced Cholangiocarcinoma With Activating FGFR2 Gene Alterations
Start Date
11/22/2023
Completion Date
9/1/2027
Summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of TYRA-200 in cancers with FGFR2 activating gene alterations, including unresectable locally advanced/metastatic intrahepatic cholangiocarcinoma and other advanced solid tumors.
Detailed Description
This is a single arm, multi-part, phase 1 clinical trial studying TYRA-200, a novel, potent fibroblast growth factor receptor (FGFR) 1/2/3 tyrosine kinase inhibitor, in unresectable locally advanced/metastatic intrahepatic cholangiocarcinoma and other advanced solid tumors with activating alterations in FGFR2. Part A is a dose escalation study in participants with any advanced solid tumor with FGFR/FGF pathway alterations who have exhausted approved standard therapies. Part A will evaluate the safety, tolerability, and PK of TYRA-200 to determine the optimal and maximum tolerated dose (MTD). Part B will evaluate the preliminary antitumor activity of TYRA-200 in participants with unresectable locally advanced/metastatic intrahepatic cholangiocarcinoma who have previously received an FGFR inhibitor and have FGFR2 kinase-domain mutations resistant to other FGFR inhibitors.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Phase 1 Part A - dose escalation TYRA-200 taken once daily by mouth in 28-day cycles
Phase 1 Part B - dose expansion TYRA-200 taken once daily by mouth in 28-day cycles
Conditions
Locations
University of California San Francisco (UCSF)
San Francisco, California 94143
United States
Massachusetts General Hospital
Boston, Massachusetts 02114
United States
The Ohio State University
Columbus, Ohio 43210
United States
The University of Texas MD Anderson Cancer Center
Houston, Texas 77030
United States