RecruitingPhase 1

Safety and Preliminary Anti-Tumor Activity of TYRA-430 in Advanced Hepatocellular Carcinoma and Other Solid Tumors With Activating FGF/FGFR Pathway Aberrations

United States100 participantsStarted 2025-04-24

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

✕. Any immunotherapy or other antibody therapy within 28 days prior to the first dose of the study drug.
✕. A TKI \< 5 days or 5X the terminal Phase elimination half-lives, whichever is longer, prior to the first dose of TYRA-430.
✕. Other systemic therapy not listed above \< 14 days prior to the first dose of the study drug.

What they're measuring

Maximum tolerated dose (MTD)

Timeframe: Up to 1 year

Rate and severity of adverse events of TYRA-430 as monotherapy

Timeframe: First dose of study drug through 28 days after the last dose of study drug

Recommended Phase 2 dose(s) of TYRA-430

Timeframe: Up to 2 years

Trial details

NCT IDNCT06915753

SponsorTyra Biosciences, Inc

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-01

Contact for this trial

Grace Indyk

858-356-2323 TyraClinicalTrials@tyra.bio

View on ClinicalTrials.gov More Metastatic Hepatocellular Carcinoma trials