A Multicenter, Open-label, First-in-Human Study of TYRA-430 in Advanced Hepatocellular Carcinoma and Other Solid Tumors With Activating FGF/FGFR Pathway Aberrations
Summary
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.
Detailed description
This is an open-label, multi-center, first-in-human, Phase 1 global study of TYRA-430, a first-in-class, selective, reversible fibroblast growth factor receptor (FGFR) 4 and 3 inhibitor, in locally advanced/metastatic hepatocellular carcinoma and other advanced solid tumors that contain FGF/FGFR pathway aberrations.
Arms & interventions
- DrugTYRA-430
Oral TYRA-430 given daily.
Outcome measures
Primary
Maximum tolerated dose (MTD)
MTD determination: dose limiting toxicity (DLT) rate in the first 28-day cycle
Time frame: Up to 1 year
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
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
Cmax
Time frame: Up to 2 years
Tmax
Time frame: Up to 2 years
AUC0-last
Time frame: Up to 2 years
AUCTau
Time frame: Up to 2 years
AUC0-∞
Time frame: Up to 2 years
Vd/F
Time frame: Up to 2 years
CL/F
Time frame: Up to 2 years
t1/2
Time frame: Up to 2 years
Overall Response Rate (ORR)
Time frame: Up to 3.5 years
Duration of Response (DOR)
Time frame: Up to 3.5 years
Disease Control Rate (DCR)
Time frame: Up to 3.5 years
Time to Response (TTR)
Time frame: Up to 3.5 years
Eligibility criteria
Study locations (9)
USC Norris Comprehensive Cancer Center
Los Angeles, California, 90033
UCSF Medical Center at Mount Zion
San Francisco, California, 94158
Stanford Cancer Institute
Stanford, California, 94305
The University of Kansas Medical Center
Westwood, Kansas, 66205
John Hopkins University
Baltimore, Maryland, 21205
Mass General Cancer Center
Boston, Massachusetts, 02114
Karmanos Cancer Institute
Detroit, Michigan, 48201
Columbia University Irving Medical Center
New York, New York, 10043
Sarah Cannon Research Institute Oncology Partners
Nashville, Tennessee, 37203