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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Tyra Biosciences, Inc
Study ID
NCT06915753
Phase
PHASE1
Status
Recruiting
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Conditions

  • Advanced Solid Tumors
  • FGF19 Gene Amplification
  • FGF19 Gene Overexpression
  • FGFR Gene Alterations
  • FGFR Gene Amplification
  • FGFR3 Gene Alteration
  • FGFR3 Gene Fusions
  • FGFR3 Gene Mutation
  • FGFR4 Gene Fusions
  • FGFR4 Gene Mutation
  • Locally Advanced Unresectable Hepatocellular Carcinoma
  • Metastatic Hepatocellular Carcinoma
  • Solid Tumor, Adult
  • Solid Tumors

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • TYRA-430 — DRUG
    Oral TYRA-430 given daily.

Study Details

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.

Key Dates

Start date
Apr 24, 2025
Status verified
Nov 2025
Primary completion
Jan 31, 2028
Completion
Sep 30, 2028

Study Design

Enrollment
100 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part A - Dose Escalation
    Dose escalation of TYRA-430 as monotherapy at various dose levels.
  • Experimental: Part B - Cohort 1 Dose Expansion
    Dose expansion group for TYRA-430 monotherapy in advanced HCC at a dose(s) determined in Part A.
  • Experimental: Part B - Cohort 2 Dose Expansion
    Dose expansion group for TYRA-430 monotherapy in advanced solid tumors at a dose(s) determined in Part A.

Primary Outcome Measure

Maximum tolerated dose (MTD) [ Time Frame: Up to 1 year ]

Central Contacts

Locations (9)

FacilityCityStateZIPSite coordinators
USC Norris Comprehensive Cancer CenterLos AngelesCalifornia90033-
UCSF Medical Center at Mount ZionSan FranciscoCalifornia94158-
Stanford Cancer InstituteStanfordCalifornia94305-
The University of Kansas Medical CenterWestwoodKansas66205-
John Hopkins UniversityBaltimoreMaryland21205-
Mass General Cancer CenterBostonMassachusetts02114-
Karmanos Cancer InstituteDetroitMichigan48201-
Columbia University Irving Medical CenterNew YorkNew York10043-
Sarah Cannon Research Institute Oncology PartnersNashvilleTennessee37203-

Find similar trials in Los Angeles, CA

By research site
USC Norris Comprehensive Cancer Center· Los Angeles, CAUCSF Medical Center at Mount Zion· San Francisco, CAStanford Cancer Institute· Stanford, CAThe University of Kansas Medical Center· Westwood, KSJohn Hopkins University· Baltimore, MDMass General Cancer Center· Boston, MA

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