Health Trials

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

ConditionsMetastatic Hepatocellular CarcinomaSolid TumorsSolid Tumor, AdultFGFR Gene AmplificationFGFR Gene AlterationsFGFR3 Gene AlterationFGFR3 Gene MutationAdvanced Solid TumorsFGFR4 Gene MutationFGFR4 Gene FusionsFGF19 Gene AmplificationFGF19 Gene OverexpressionFGFR3 Gene FusionsLocally Advanced Unresectable Hepatocellular Carcinoma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorTyra Biosciences, Inc

About this trial

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.

Eligibility criteria

Qualifiers

Age ≥ 18 years

Eastern Cooperative Oncology Group (ECOG) performance status of ≤1.

Adequate end organ function.

Ability to swallow oral formulations.

Disqualifiers

Have disease that is suitable for local therapy administered with curative intent.

Have not recovered from reversible toxicity of prior anticancer therapy to < Grade 1 or baseline (except toxicities that are not clinically significant or not expected to resolve, including but not limited to, alopecia, fatigue, skin discoloration, or Grade 1 neuropathy).

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.

Trial design

Treatments tested in this trial

  • TYRA-430

Treatment groups

100 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Tyra Biosciences, Inc

Lead sponsor

Source ClinicalTrials.gov