OncoMatch/Clinical Trials/NCT06915753
Safety and Preliminary Anti-Tumor Activity of TYRA-430 in Advanced Hepatocellular Carcinoma and Other Solid Tumors With Activating FGF/FGFR Pathway Aberrations
Official title: A Multicenter, Open-label, First-in-Human Study of TYRA-430 in Advanced Hepatocellular Carcinoma and Other Solid Tumors With Activating FGF/FGFR Pathway Aberrations
Is NCT06915753 recruiting? Yes, currently enrolling (Oct 2026). This Phase 1 trial studies TYRA-430 for metastatic hepatocellular carcinoma.
Treatment: TYRA-430 — A Phase 1 study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamic (PD), and preliminary antitumor activity of TYRA-430 in cancers with FGF/FGFR pathway aberrations, including locally advanced/metastatic hepatocellular carcinoma and other advanced solid tumors.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Hepatocellular Carcinoma
Tumor Agnostic
Biomarker criteria
Required: FGFR4 activating gain-of-function mutation
Must have an eligible activating gain-of-function alteration in the FGFR4 gene
Required: FGF19 focal amplification
focal amplifications of FGF19
Required: FGF19 overexpression
FGF19 IHC testing
Required: FGF19 amplification
advanced solid tumor with documented FGF/FGFR pathway alterations
Required: FGFR4 mutation
advanced solid tumor with documented FGF/FGFR pathway alterations
Required: FGFR4 fusion
advanced solid tumor with documented FGF/FGFR pathway alterations
Disease stage
Required: Stage III, IV
locally advanced unresectable/metastatic HCC or histologically confirmed advanced solid tumor
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: standard of care — appropriate for tumor type
Must have previously received SOC appropriate for their tumor type. Any number of prior therapies, including FGFR inhibitors, are permitted.
Cannot have received: pan-FGFR inhibitor
Prior treatment with pan-FGFR inhibitors or FGFR4-selective inhibitors
Cannot have received: FGFR4-selective inhibitor
Prior treatment with pan-FGFR inhibitors or FGFR4-selective inhibitors
Cannot have received: anti-FGFR therapy
Exception: discontinued due to significant toxicity
Participant discontinued a prior anti-FGFR therapy due to significant toxicity
Lab requirements
Blood counts
Kidney function
Liver function
Adequate end organ function
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- USC Norris Comprehensive Cancer Center · Los Angeles, California
- UCSF Medical Center at Mount Zion · San Francisco, California
- Stanford Cancer Institute · Stanford, California
- The University of Kansas Medical Center · Westwood, Kansas
- John Hopkins University · Baltimore, Maryland
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06915753 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior pan-FGFR inhibitor, FGFR4-selective inhibitor, anti-FGFR therapy disqualifies patients from enrollment.
Does this trial require FGFR4?
Yes, FGFR4 activating gain-of-function mutation is a required biomarker for enrollment.
Does this trial require FGF19?
Yes, FGF19 focal amplification is a required biomarker for enrollment.
Does this trial require FGF19?
Yes, FGF19 overexpression 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