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TYRA-200 for Advanced Cholangiocarcinoma with FGFR2 Gene Alterations

This study is testing a new oral medicine called TYRA-200 for people with advanced cancers, including cholangiocarcinoma (a type of bile duct cancer), that have specific changes in their FGFR2 gene. TYRA-200 is designed to block certain proteins (FGFR 1/2/3 tyrosine kinases) that can help cancer grow. The main goals are to find the safest and most effective dose of TYRA-200 and to see how well it works against the cancer. You might be able to join if you have an advanced solid tumor with certain FGFR/FGF gene changes and have already tried other standard treatments. The study is currently enrolling about 40 participants.

Study design
This is a single-arm, multi-part Phase 1 study. It will involve about 40 participants to test TYRA-200.
What's involved
TYRA-200 is taken once daily by mouth in 28-day cycles. The study will measure safety and dose for at least 28 days.
Compensation
Not stated in the trial record.
Follow-up
The study will determine the optimal dose of TYRA-200 for up to approximately 18 months after starting treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06160752

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

Active, Not Recruiting
PHASE1Ages 18+InterventionalTreatment
Tyra Biosciences, Inc
~40 participants
Updated 2026-08-05 on ClinicalTrials.gov
What's tested:Phase 1 Part A - dose escalation TYRA-200 taken once daily by mouth in 28-day cyclesPhase 1 Part B - dose expansion TYRA-200 taken once daily by mouth in 28-day cycles

At a glance

Recruiting sites
0 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Phase 1 Part A: To determine the maximum tolerated dose (MTD) of TYRA-200.
Measured over Initiation of study treatment through 28 Days
+1 more outcome measured

Conditions

Locally Advanced Cholangiocarcinoma
Intrahepatic Cholangiocarcinoma
Solid Tumor
Metastatic Cholangiocarcinoma

Explore related trials

CholangiocarcinomaSolid Neoplasm

Where it's being run

4 sites across 4 states
California1
Massachusetts1
Ohio1
Texas1

Study leadership

  • Doug Warner · STUDY_CHAIR · Tyra Biosciences, Inc

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.

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.

What this trial measures

  • Phase 1 Part A: To determine the maximum tolerated dose (MTD) of TYRA-200.Initiation of study treatment through 28 Days
  • Phase 1 Part B: To determine the optimal dose of TYRA-200.Initiation of study treatment through 28 days (up to approximately 18 months