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TYRA-200

Phase 1

Locally Advanced Cholangiocarcinoma | Small molecule | Oncology |Tyra Biosciences, Inc.|Last Updated: Aug 5, 2026

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment40

FDA Designations

No designations recorded

Clinical trial landscape

TYRA-200 · 1 trial · 4 indications

Phase 1 1
NCT06160752Safety and Anti-Tumor Activity of TYRA-200 in Advanced Cholangiocarcinoma With Activating FGFR2 Gene AlterationsLocally Advanced Cholangiocarcinoma
ACTIVE NOT_RECRUITING40 Analytics
PHASE1ACTIVE NOT_RECRUITING
Safety and Anti-Tumor Activity of TYRA-200 in Advanced Cholangiocarcinoma With Activating FGFR2 Gene Alterations
Locally Advanced Cholangiocarcinoma
NCT0616075240
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Study Endpoints

Primary Endpoints

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

Secondary Endpoints

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)
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)
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Phase 1 Part A and Part BEXPERIMENTALTYRA-200 taken once daily by mouth in 28-day cycles

Interventions

NameTypeDescription
Phase 1 Part A - dose escalation TYRA-200 taken once daily by mouth in 28-day cyclesDRUGTYRA-200 is an oral, novel potent FGFR 1/2/3 tyrosine kinase inhibitor that targets tumors that contain activating gene alterations of FGFR2.
Phase 1 Part B - dose expansion TYRA-200 taken once daily by mouth in 28-day cyclesDRUGTYRA-200 is an oral, novel potent FGFR 1/2/3 tyrosine kinase inhibitor that targets tumors that contain activating gene alterations of FGFR2.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: Phase 1 Part A * Men and women 18 years of age or older. * Eastern Cooperative Oncology Group (ECOG) performance status of ≤1. * Any histologically confirmed advanced solid tumor with FGFR/FGF pathway alterations including FGFR gene mutations, fusions, and amplifications, as we...

Countries:United States
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Recent Changes (Last 90 Days)

MEDIUMAug 5, 2026NCT06160752Status: RECRUITING → ACTIVE_NOT_RECRUITING
LOWJul 29, 2026NCT06160752lastUpdatePostDate: changed
LOWJul 29, 2026NCT06160752lastUpdatePostDate: changed