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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

Is NCT06915753 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies TYRA-430 for metastatic hepatocellular carcinoma.

Phase 1RecruitingTyra Biosciences, IncNCT06915753Data as of May 2026

Treatment: TYRA-430A 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.

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Extracted eligibility criteria

Cancer type

Hepatocellular Carcinoma

Tumor Agnostic

Biomarker criteria

Required: FGFR3 activating gain-of-function mutation

Must have an eligible activating gain-of-function alteration in the FGFR3 or FGFR4 gene

Required: FGFR4 activating gain-of-function mutation

Must have an eligible activating gain-of-function alteration in the FGFR3 or FGFR4 gene

Required: FGF19 focal amplification

focal amplifications of FGF19

Disease stage

Required: Stage III, IV, BARCELONA CLINIC LIVER CANCER (BCLC) STAGE B THAT IS NOT ELIGIBLE FOR LOCOREGIONAL THERAPY, STAGE C (BCLC)

locally advanced unresectable/metastatic HCC; BCLC stage B that is not eligible for locoregional therapy, or stage C

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Min 1 prior line

Must have received: standard of care

Must have previously received SOC appropriate for their tumor type

Cannot have received: pan-FGFR inhibitor

Prior treatment with pan-FGFR inhibitors

Cannot have received: FGFR4-selective inhibitor

Prior treatment with ... FGFR4-selective inhibitors

Cannot have received: anti-FGFR therapy

Exception: Discontinued due to significant toxicity, defined as hepatotoxicity ≥ Grade 3 or any Grade 4 toxicity

Participant 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

Lab requirements

Liver function

child-pugh score class a

Cardiac function

no uncontrolled cardiovascular disease

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 →

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