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

NCT06160752 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-10-03

No results posted yet for this study

Summary

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.

Conditions

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

Interventions

DRUG

Phase 1 Part A - dose escalation 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.

DRUG

Phase 1 Part B - dose expansion 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.

Sponsors & Collaborators

  • Tyra Biosciences, Inc

    lead INDUSTRY

Principal Investigators

  • Doug Warner · Tyra Biosciences, Inc

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-22
Primary Completion
2026-09-30
Completion
2027-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06160752 on ClinicalTrials.gov