RECRUITING

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

Conditions

Locally Advanced Cholangiocarcinoma Intrahepatic Cholangiocarcinoma Solid Tumor Metastatic Cholangiocarcinoma FGFR2 gene activation FGFR2 gene alterations FGFR2 gene fusion/rearrangement FGFR2 gene mutation FGFR2 gene translocation FGFR2 Fibroblast growth factor receptor 2 (FGFR2)Fibroblast growth factor receptor 2 alterations locally advanced cancer metastatic cancer solid tumors cholangiocarcinoma unresectable cholangiocarcinoma fibroblast growth factor receptor inhibitor

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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)

Quick Facts

Study Start:2023-11-22

Study Completion:2027-09

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06160752

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 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. * 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.	* 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.

Inclusion Criteria

Exclusion Criteria

* 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.
* 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.

* 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.

Contacts and Locations

Study Contact

Grace Indyk

CONTACT

(619)728-4805

TyraClinicalTrials@tyra.bio

Principal Investigator

Doug Warner

STUDY_CHAIR

Tyra Biosciences, Inc

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Tyra Biosciences, Inc

Doug Warner, STUDY_CHAIR, Tyra Biosciences, Inc

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-22

Study Completion Date2027-09

Study Record Updates

Study Start Date2023-11-22

Study Completion Date2027-09

Terms related to this study

Keywords Provided by Researchers

FGFR2 gene activation
FGFR2 gene alterations
FGFR2 gene fusion/rearrangement
FGFR2 gene mutation
FGFR2 gene translocation
FGFR2
Fibroblast growth factor receptor 2 (FGFR2)
Fibroblast growth factor receptor 2 alterations
locally advanced cancer
metastatic cancer
solid tumors
cholangiocarcinoma
intrahepatic cholangiocarcinoma
unresectable cholangiocarcinoma
metastatic cholangiocarcinoma
fibroblast growth factor receptor inhibitor

Additional Relevant MeSH Terms

Locally Advanced Cholangiocarcinoma
Intrahepatic Cholangiocarcinoma
Solid Tumor
Metastatic Cholangiocarcinoma