Safety and Anti-Tumor Activity of TYRA-200 in Advanced Cholangiocarcinoma With Activating FGFR2 Gene Alterations

Part of paid clinical trials in San Francisco, California.

Sponsor
Tyra Biosciences, Inc
Study ID
NCT06160752
Phase
PHASE1
Status
Recruiting
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Conditions

  • Intrahepatic Cholangiocarcinoma
  • Locally Advanced Cholangiocarcinoma
  • Metastatic Cholangiocarcinoma
  • Solid Tumor

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Nov 22, 2023
Status verified
Oct 2024
Primary completion
Sep 30, 2026
Completion
Sep 30, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1 Part A and Part B
    TYRA-200 taken once daily by mouth in 28-day cycles

Primary Outcome Measure

Phase 1 Part A: To determine the maximum tolerated dose (MTD) of TYRA-200. [ Time Frame: Initiation of study treatment through 28 Days ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
University of California San Francisco (UCSF)San FranciscoCalifornia94143
Quincy Harris
415-502-3310
Massachusetts General HospitalBostonMassachusetts02114
Haley Ellis, MD
617-724-4000
The Ohio State UniversityColumbusOhio43210-
The University of Texas MD Anderson Cancer CenterHoustonTexas77030
Jodi Rodon Ahnert, MD
713-792-5603

Find similar trials in San Francisco, CA

By research site
University of California San Francisco (UCSF)· San Francisco, CAMassachusetts General Hospital· Boston, MAThe Ohio State University· Columbus, OHThe University of Texas MD Anderson Cancer Center· Houston, TX

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