TYRA-430 for Advanced Liver Cancer and Other Solid Tumors with FGFR Changes
This study is testing a new drug called TYRA-430 for people with advanced hepatocellular carcinoma (a type of liver cancer) or other solid tumors. To join, your cancer must have specific changes in the FGFR gene. TYRA-430 is given daily by mouth. Researchers want to find the safest dose of TYRA-430 and see how well it works against these cancers. They will also track any side effects you might experience. This is a Phase 1 study, meaning it's one of the first times TYRA-430 is being tested in people. The study aims to enroll about 100 participants.
- Study design
- This is an open-label, multi-center, first-in-human Phase 1 study. It is designed to evaluate TYRA-430 in approximately 100 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- You would be monitored for side effects from the first dose through 28 days after your last dose of TYRA-430.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT06915753
Safety and Preliminary Anti-Tumor Activity of TYRA-430 in Advanced Hepatocellular Carcinoma and Other Solid Tumors With Activating FGF/FGFR Pathway Aberrations
Recruiting
PHASE1Ages 18+InterventionalTreatmentTyra Biosciences, Inc
~100 participants
Updated 2026-07-29 on ClinicalTrials.gov
What's tested:TYRA-430
At a glance
Recruiting sites
16 of 16 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Maximum tolerated dose (MTD)
Measured over Up to 1 year
+2 more outcomes measured
Conditions
Where it's being run
16 sites across 10 statesSouth Korea4
California3
Taiwan2
Kansas1
Maryland1
Massachusetts1
Michigan1
New York1
Study leadership
- Doug Warner, MD · STUDY_CHAIR · Tyra Biosciences, Inc
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Age ≥ 18 years
Eastern Cooperative Oncology Group (ECOG) performance status of ≤1.
Adequate end organ function.
Ability to swallow oral formulations.
Ability to understand and willingness to sign the ICF.
Histologically confirmed locally advanced unresectable/metastatic HCC or histologically confirmed advanced solid tumor with documented FGF/FGFR pathway alterations
For participants with histologically confirmed locally advanced or metastatic HCC:
Barcelona Clinic Liver Cancer (BCLC) stage B that is not eligible for locoregional therapy, or stage C.
Child-Pugh Score class A
Must have previously received SOC appropriate for their tumor type. Any number of prior therapies, including FGFR inhibitors, are permitted.
Agree to provide archival tumor tissue no older than 2 years from the time of enrollment, if available. If an archived specimen is not available, a biopsy is not required.
Histologically confirmed locally advanced/metastatic HCC who have previously received standard of care.
Barcelona Clinic Liver Cancer (BCLC) stage B that is not eligible for locoregional therapy, or stage C.
Child-Pugh Score class A
Availability of an archival formalin-fixed paraffin-embedded (FFPE) tumor tissue specimen obtained ≤2 years prior to screening for submission to sponsor-designated central laboratory for FGF19 IHC testing.
At least 1 measurable lesion by RECIST v1.1.
Histologically confirmed advanced solid tumor except FGFR3-altered urothelial carcinoma and primary central nervous system tumors who have previously received standard of care. Note: Participants with confirmed diagnosis of locally advanced or metastatic HCC are not eligible for Cohort 2.
Must have an eligible activating gain-of-function alteration in the FGFR3 or FGFR4 gene, or focal amplifications of FGF19
Archival tumor tissue biopsy specimen no older than 2 years from the time of enrollment, if available. If a tissue biopsy specimen is not available, a biopsy is not required.
At least 1 measurable lesion by RECIST v1.1.
Exclusion
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).
Have received the following anticancer therapy:
Participant discontinued a prior anti-FGFR therapy due to significant toxicity, defined as hepatotoxicity ≥ Grade 3 or any Grade 4 toxicity according to CTCAE v5.0.
Has a serum phosphorus level \> upper limit of normal (ULN) during screening that remains \>ULN despite medical management.
History of or current uncontrolled cardiovascular disease.
Active, symptomatic, or untreated brain metastases.
Have a diagnosis of primary CNS malignancies.
Gastrointestinal disorders that will affect oral administration or absorption of TYRA-430.
Females who are pregnant, breastfeeding, or planning to become pregnant and males who plan to father a child while enrolled in this study.
Any reason that, in the view of investigator, would substantially impair the ability of the participant to comply with study procedures and increase the risk to the participant.
Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC.
Prior treatment with pan-FGFR inhibitors or FGFR4-selective inhibitors.
Histologically confirmed locally advanced/metastatic HCC.
Histologically confirmed urothelial cancer.
What this trial measures
- Maximum tolerated dose (MTD)Up to 1 year
MTD determination: dose limiting toxicity (DLT) rate in the first 28-day cycle
- Rate and severity of adverse events of TYRA-430 as monotherapyFirst dose of study drug through 28 days after the last dose of study drug
Number of participants with TEAEs as assessed by CTCAE, v5.0
- Recommended Phase 2 dose(s) of TYRA-430Up to 2 years
To determine recommended Phase 2 dose(s) of TYRA-430