Status:
RECRUITING
Safety and Anti-Tumor Activity of TYRA-200 in Advanced Cholangiocarcinoma With Activating FGFR2 Gene Alterations
Lead Sponsor:
Tyra Biosciences, Inc
Conditions:
Locally Advanced Cholangiocarcinoma
Intrahepatic Cholangiocarcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 un...
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/m...
Eligibility Criteria
Inclusion
- Phase 1 Part A
- Men and women 18 years of age or older.
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤1.
- Any histologically confirmed advanced solid tumor with FGFR/FGF pathway alterations including FGFR gene mutations, fusions, and amplifications, as well as gene amplifications of FGFR ligands, who have exhausted or refused approved standard therapies.
- Evaluable disease according to RECIST v1.1.
- Phase 1 Part B
- Men and women 18 years of age or older.
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤1.
- Histologically confirmed locally advanced/metastatic intrahepatic cholangiocarcinoma with a previously identified FGFR2 gene mutation or rearrangement.
- Must have received a prior FGFR inhibitor. Participants may have received more than 1 prior FGFR inhibitor.
- Presence of an FGFR2 kinase domain mutation that confers resistance to previous/other FGFR inhibitors; resistance mutations should be identified by a US Food and Drug Administration authorized/approved companion diagnostic or a Clinical Laboratory Improvement Amendments (CLIA) validated local test performed in a certified laboratory.
- At least 1 measurable lesion by RECIST v1.1.
Exclusion
- Discontinued a prior anti-FGFR therapy due to significant toxicity, defined as hepatotoxicity ≥Grade 3 or any Grade 4 toxicity according to CTCAE v5.0.
- Has a serum phosphorus level \> upper limit of normal (ULN) during screening that remains \>ULN despite medical management.
- Any ocular condition likely to increase the risk of eye toxicity.
- History of or current uncontrolled cardiovascular disease.
- Active, symptomatic, or untreated brain metastases.
- Gastrointestinal disorders that will affect oral administration or absorption of TYRA-200.
- Females who are pregnant, breastfeeding, or planning to become pregnant and males who plan to father a child while enrolled in this study.
Key Trial Info
Start Date :
November 22 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2027
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06160752
Start Date
November 22 2023
End Date
September 1 2027
Last Update
October 3 2024
Active Locations (4)
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1
University of California San Francisco (UCSF)
San Francisco, California, United States, 94143
2
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
3
The Ohio State University
Columbus, Ohio, United States, 43210
4
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030