OncoMatch/Clinical Trials/NCT06160752
Safety and Anti-Tumor Activity of TYRA-200 in Advanced Cholangiocarcinoma With Activating FGFR2 Gene Alterations
Is NCT06160752 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1 trial studies multiple treatments including Phase 1 Part A - dose escalation TYRA-200 taken once daily by mouth in 28-day cycles and Phase 1 Part B - dose expansion TYRA-200 taken once daily by mouth in 28-day cycles for locally advanced cholangiocarcinoma.
Treatment: Phase 1 Part A - dose escalation TYRA-200 taken once daily by mouth in 28-day cycles · Phase 1 Part B - dose expansion TYRA-200 taken once daily by mouth in 28-day cycles — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Cholangiocarcinoma
Tumor Agnostic
Biomarker criteria
Required: FGFR2 mutation
FGFR2 gene mutation
Required: FGFR2 rearrangement
FGFR2 gene rearrangement
Required: FGFR2 kinase domain mutation that confers resistance to previous/other FGFR inhibitors
Presence of an FGFR2 kinase domain mutation that confers resistance to previous/other FGFR inhibitors
Allowed: FGFR1 mutation
FGFR gene mutations
Allowed: FGFR1 fusion
FGFR gene fusions
Allowed: FGFR1 amplification
FGFR gene amplifications
Allowed: FGFR3 mutation
FGFR gene mutations
Allowed: FGFR3 fusion
FGFR gene fusions
Allowed: FGFR3 amplification
FGFR gene amplifications
Allowed: FGFR4 mutation
FGFR gene mutations
Allowed: FGFR4 fusion
FGFR gene fusions
Allowed: FGFR4 amplification
FGFR gene amplifications
Allowed: FGF3 amplification
gene amplifications of FGFR ligands
Allowed: FGF4 amplification
gene amplifications of FGFR ligands
Allowed: FGF19 amplification
gene amplifications of FGFR ligands
Disease stage
Required: Stage III, IV
locally advanced/metastatic intrahepatic cholangiocarcinoma; Any histologically confirmed advanced solid tumor
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: FGFR inhibitor
Must have received a prior FGFR inhibitor. Participants may have received more than 1 prior FGFR inhibitor.
Cannot have received: anti-FGFR therapy
Exception: Discontinued due to significant toxicity, defined as hepatotoxicity ≥Grade 3 or any Grade 4 toxicity according to CTCAE v5.0
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
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of California San Francisco (UCSF) · San Francisco, California
- Massachusetts General Hospital · Boston, Massachusetts
- The Ohio State University · Columbus, Ohio
- The University of Texas MD Anderson Cancer Center · Houston, Texas
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06160752 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior anti-FGFR therapy disqualifies patients from enrollment.
Does this trial require FGFR2?
Yes, FGFR2 mutation is a required biomarker for enrollment.
Does this trial require FGFR2?
Yes, FGFR2 rearrangement is a required biomarker for enrollment.
Does this trial require FGFR2?
Yes, FGFR2 kinase domain mutation that confers resistance to previous/other FGFR inhibitors is a required biomarker for enrollment.
What disease stage is eligible?
Stage III or IV is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages