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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 AlterationsAdvanced Solid TumorsFGFR4 Gene MutationFGFR4 Gene FusionsFGF19 Gene AmplificationFGF19 Gene OverexpressionLocally 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

This trial does not accept healthy volunteers

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

Design model

Sequential

Treatments tested in this trial

  • TYRA-430

    Drug

    Oral TYRA-430 given daily.

Treatment groups

125 Participants
are divided into 3 treatment groups
Group A: Part A - Dose EscalationExperimental treatment 1 intervention
Group B: Part B - Cohort 1 Dose ExpansionExperimental treatment 1 intervention
Group C: Part B - Cohort 2 Dose ExpansionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Maximum tolerated dose (MTD)

MTD determination: dose limiting toxicity (DLT) rate in the first 28-day cycle

Time frame
Up to 1 year
2

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

Number of participants with TEAEs as assessed by CTCAE, v5.0

Time frame
First dose of study drug through 28 days after the last dose of study drug
3

Recommended Phase 2 dose(s) of TYRA-430

To determine recommended Phase 2 dose(s) of TYRA-430

Time frame
Up to 2 years

Secondary outcomes

1

Cmax

Time frame
Up to 2 years
2

Tmax

Time frame
Up to 2 years
3

AUC0-last

Time frame
Up to 2 years
4

AUCTau

Time frame
Up to 2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tyra Biosciences, Inc

Lead sponsor

Source ClinicalTrials.gov
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