Study on the Safety and Early Effects of TYRA-300 in Advanced Bladder Cancer and Other Tumors with FGFR3 Gene Changes

Sponsor: Tyra Biosciences, Inc

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05544552

Provider View

This clinical trial is testing a new drug, TYRA-300, to see if it is safe and can help treat cancers with specific FGFR3 gene changes, including advanced bladder cancer and other solid tumors.

Patient Parameters

Program Overview

The study aims to evaluate the safety, how the body processes the drug, and the initial effects of TYRA-300 in patients with cancers that have FGFR3 gene changes. This includes advanced bladder cancer and other solid tumors that have spread or cannot be removed by surgery.

Description

This clinical trial is divided into two phases. In Phase 1, researchers will test different doses of TYRA-300 to find the safest and most effective dose for patients with advanced bladder cancer and other tumors with FGFR3 gene changes. This phase will help determine the best dose to use in the next phase. In Phase 2, the study will focus on how well TYRA-300 works in shrinking tumors in patients with these specific gene changes. The trial is open to adults with advanced cancers who have tried other treatments without success. Participants will receive TYRA-300 and be monitored for side effects and how well the drug works against their cancer.

Eligibility Criteria

Inclusion Criteria

Phase 1:

  • Adults aged 18 or older.
  • Good overall health with an ECOG performance status of 0 or 1.
  • Have advanced solid tumors that have not responded to standard treatments.
  • Have tumors that can be evaluated or measured by scans.
  • Have a confirmed FGFR3 gene mutation or fusion in their cancer.

Phase 2:

  • Adults aged 18 or older.
  • Good overall health with an ECOG performance status of 0-2 or a Karnofsky score over 70.
  • Have at least one tumor that can be measured by scans.
  • Have advanced or metastatic cancer in one of the following categories:
    • Bladder cancer with an FGFR3 gene mutation or rearrangement that has worsened after previous FGFR inhibitor treatment and has a resistance mutation.
    • Bladder cancer with an FGFR3 gene mutation or rearrangement that has not been treated with an FGFR inhibitor.
    • Any solid tumor with an FGFR3 gene mutation or rearrangement.

Exclusion Criteria

  • High phosphorus levels in the blood that cannot be controlled with treatment.
  • Eye conditions that could increase the risk of eye problems.
  • Uncontrolled heart disease.
  • Active, symptomatic, or untreated cancer spread to the brain.
  • Digestive issues that affect taking or absorbing the drug TYRA-300.
  • Women who are pregnant, breastfeeding, or planning to become pregnant, and men planning to father a child during the study.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.