RecruitingPhase 1NCT06160752

Safety and Anti-Tumor Activity of TYRA-200 in Advanced Cholangiocarcinoma With Activating FGFR2 Gene Alterations

A Multicenter, Open-label, First-in-Human Study of TYRA-200 in Advanced Intrahepatic Cholangiocarcinoma and Other Solid Tumors With Activating FGFR2 Gene Alterations (SURF-201)


Sponsor

Tyra Biosciences, Inc

Enrollment

40 participants

Start Date

Nov 22, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new targeted drug called TYRA-200 in patients with advanced cholangiocarcinoma (bile duct cancer) that has a specific genetic change called an FGFR2 gene alteration. TYRA-200 is designed to block the abnormal FGFR2 protein that drives tumor growth. **You may be eligible if...** - You are 18 years or older - You have been diagnosed with advanced cholangiocarcinoma (bile duct cancer) confirmed by biopsy - Your tumor has an FGFR2 gene mutation, fusion, or amplification detected by a gene panel test - Your overall health and ability to function meets the required performance criteria - You have previously tried standard treatments or are not a candidate for them **You may NOT be eligible if...** - Your tumor does not have an FGFR2 gene alteration - You have not yet tried available standard therapies and are still eligible for them - Your general health or organ function does not meet the required thresholds - You have conditions that make FGFR-targeted therapy unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPhase 1 Part A - dose escalation TYRA-200 taken once daily by mouth in 28-day cycles

TYRA-200 is an oral, novel potent FGFR 1/2/3 tyrosine kinase inhibitor that targets tumors that contain activating gene alterations of FGFR2.

DRUGPhase 1 Part B - dose expansion TYRA-200 taken once daily by mouth in 28-day cycles

TYRA-200 is an oral, novel potent FGFR 1/2/3 tyrosine kinase inhibitor that targets tumors that contain activating gene alterations of FGFR2.


Locations(4)

University of California San Francisco (UCSF)

San Francisco, California, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

The Ohio State University

Columbus, Ohio, United States

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT06160752


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