Actively Recruiting
Safety and Anti-Tumor Activity of TYRA-200 in Advanced Cholangiocarcinoma With Activating FGFR2 Gene Alterations
Led by Tyra Biosciences, Inc · Updated on 2024-10-03
40
Participants Needed
4
Research Sites
197 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Safety and Anti-Tumor Activity of TYRA-200 in Advanced Cholangiocarcinoma With Activating FGFR2 Gene Alterations
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women 18 years of age or older
- Eastern Cooperative Oncology Group (ECOG) performance status of 1 or less
- Histologically confirmed advanced solid tumor with FGFR/FGF pathway alterations including FGFR gene mutations, fusions, amplifications, or FGFR ligand gene amplifications who have exhausted or refused approved standard therapies (Part A)
- Evaluable disease according to RECIST v1.1 (Part A)
- Histologically confirmed locally advanced or metastatic intrahepatic cholangiocarcinoma with FGFR2 gene mutation or rearrangement (Part B)
- Prior treatment with at least one FGFR inhibitor (Part B)
- Presence of an FGFR2 kinase domain mutation conferring resistance to other FGFR inhibitors confirmed by FDA-approved or CLIA-validated test (Part B)
- At least one measurable lesion by RECIST v1.1 (Part B)
You will not qualify if you...
- Discontinued prior anti-FGFR therapy due to significant toxicity including hepatotoxicity Grade 3 or higher or any Grade 4 toxicity
- Serum phosphorus level above the upper limit of normal during screening that is not controlled despite medical management
- Any eye condition that increases the risk of eye toxicity
- History or current uncontrolled cardiovascular disease
- Active, symptomatic, or untreated brain metastases
- Gastrointestinal disorders affecting oral administration or absorption of TYRA-200
- Females who are pregnant, breastfeeding, or planning pregnancy and males planning to father a child during the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
University of California San Francisco (UCSF)
San Francisco, California, United States, 94143
Actively Recruiting
2
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
3
The Ohio State University
Columbus, Ohio, United States, 43210
Actively Recruiting
4
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
G
Grace Indyk
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here