SURF201
A Multicenter, Open-label, First-in-Human Study of TYRA-200 in Advanced Intrahepatic Cholangiocarcinoma and Other Solid Tumors With Activating FGFR2 Gene Alterations (SURF-201)
Sponsor study identifier
interventional
40
1 country
4
Study Start
November 22, 2023
Actual (reported)Primary Completion
March 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
September 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of TYRA-200 in cancers with FGFR2 activating gene alterations, including unresectable locally advanced/metastatic intrahepatic cholangiocarcinoma and other advanced solid tumors.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 22, 2023
Actual (reported)November 29, 2023
Actual (reported)December 7, 2023
Actual (reported)March 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
September 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Phase 1 Part A: To determine the maximum tolerated dose (MTD) of TYRA-200.
Initiation of study treatment through 28 Days
Phase 1 Part B: To determine the optimal dose of TYRA-200.
Initiation of study treatment through 28 days (up to approximately 18 months
Number of participants with adverse events (AEs) and serious adverse events (SAEs) as a measure of safety and tolerability.
From day 1 treatment through 28-days post treatment (up to 2 years)
TYRA-200 taken once daily by mouth in 28-day cycles
TYRA-200 is an oral, novel potent FGFR 1/2/3 tyrosine kinase inhibitor that targets tumors that contain activating gene alterations of FGFR2.
TYRA-200 is an oral, novel potent FGFR 1/2/3 tyrosine kinase inhibitor that targets tumors that contain activating gene alterations of FGFR2.
University of California San Francisco (UCSF)
San Francisco, California, 94143, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
The Ohio State University
Columbus, Ohio, 43210, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Doug Warner
Tyra Biosciences, Inc
First Submitted
November 29, 2023
First Posted
December 7, 2023
Study Start
November 22, 2023
Actual (reported)Primary Completion
March 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Frequency in changes in laboratory parameters and physical signs of toxicity.
From day 1 treatment through 28-days post treatment (up to 2 years)
Pharmacokinetics: maximum plasma concentration (Cmax).
From Day 1 through Cycle 3 Day 1 (each cycle is 28 days)
Pharmacokinetics: time to reach maximum plasma concentration (Tmax).
From Day 1 through Cycle 3 Day 1 (each cycle is 28 days)
Pharmacokinetics: area under the plasma concentration-time curve (AUC).
From Day 1 through Cycle 3 Day 1 (each cycle is 28 days)
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Study Completion
September 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 14, 2026
Record last verified: 2026-10
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Source: ClinicalTrials.gov.
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