Actively Recruiting
Safety and Preliminary Anti-Tumor Activity of TYRA-430 in Advanced Hepatocellular Carcinoma and Other Solid Tumors With Activating FGF/FGFR Pathway Aberrations
Led by Tyra Biosciences, Inc · Updated on 2025-11-20
100
Participants Needed
16
Research Sites
175 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Safety and Preliminary Anti-Tumor Activity of TYRA-430 in Advanced Hepatocellular Carcinoma and Other Solid Tumors With Activating FGF/FGFR Pathway Aberrations
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate function of major organs
- Ability to swallow oral medication
- Ability to understand and willing to sign informed consent
- Histologically confirmed locally advanced unresectable/metastatic hepatocellular carcinoma or advanced solid tumor with FGF/FGFR pathway changes
- For hepatocellular carcinoma: Barcelona Clinic Liver Cancer (BCLC) stage B not eligible for locoregional therapy or stage C
- Child-Pugh Score class A for liver function
- Previously received standard of care treatment appropriate for their tumor
- Availability of archival tumor tissue no older than 2 years if possible
- At least one measurable lesion by RECIST v1.1 (for Part B cohorts)
You will not qualify if you...
- Disease suitable for curative local therapy
- Not recovered from prior anticancer therapy toxicities to Grade 1 or baseline (except certain mild toxicities)
- Received immunotherapy or antibody therapy within 28 days before study drug
- Received tyrosine kinase inhibitors within 5 days or 5 times the elimination half-life before study drug
- Received other systemic therapies within 14 days before study drug
- Discontinued prior anti-FGFR therapy due to severe toxicity
- Serum phosphorus levels above normal despite treatment
- Uncontrolled cardiovascular disease
- Active, symptomatic, or untreated brain metastases
- Primary central nervous system malignancies
- Gastrointestinal issues affecting oral drug absorption
- Pregnant or breastfeeding women and males planning to father a child during the study
- Any condition that impairs study compliance or increases risk
- Known fibrolamellar, sarcomatoid, or mixed cholangiocarcinoma and HCC (Part B Cohort 1)
- Prior treatment with pan-FGFR or FGFR4-selective inhibitors (Part B Cohort 1)
- Histologically confirmed hepatocellular carcinoma (Part B Cohort 2)
- Histologically confirmed urothelial cancer (Part B Cohort 2)
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 16 locations
1
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Actively Recruiting
2
UCSF Medical Center at Mount Zion
San Francisco, California, United States, 94158
Actively Recruiting
3
Stanford Cancer Institute
Stanford, California, United States, 94305
Actively Recruiting
4
The University of Kansas Medical Center
Westwood, Kansas, United States, 66205
Actively Recruiting
5
John Hopkins University
Baltimore, Maryland, United States, 21205
Actively Recruiting
6
Mass General Cancer Center
Boston, Massachusetts, United States, 02114
Actively Recruiting
7
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Actively Recruiting
8
Columbia University Irving Medical Center
New York, New York, United States, 10043
Actively Recruiting
9
Sarah Cannon Research Institute Oncology Partners
Nashville, Tennessee, United States, 37203
Actively Recruiting
10
University Health Network Princess Margaret Cancer Center
Toronto, Ontario, Canada, M5G 2C4
Actively Recruiting
11
Asan Medical Center
Seoul, South Korea
Actively Recruiting
12
Samsung Medical Center
Seoul, South Korea
Actively Recruiting
13
Seoul National University Hospital
Seoul, South Korea
Actively Recruiting
14
Severance Hospital, Yonsei University Health System
Seoul, South Korea
Actively Recruiting
15
National Taiwan University Hospital
Taipei, Taiwan
Actively Recruiting
16
Taipei Veterans General Hospital
Taipei, Taiwan
Actively Recruiting
Research Team
G
Grace Indyk
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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