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 (May 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
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 →
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 qualify