Study on the Effectiveness and Safety of TL118 for Patients with Solid Tumors

Sponsor: Teligene US

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06010342

This clinical trial is testing a new drug, TL118, to see if it can effectively treat patients with solid tumors that have specific genetic changes known as NTRK gene fusions.

Patient Parameters

Program Overview

The purpose of this study is to find out how well the drug TL118 works in treating solid tumors that have a specific genetic change called an NTRK gene fusion. These changes can cause cancer cells to grow and spread. TL118 is designed to block certain proteins that help these cancer cells grow.

Description

TL118 is a new oral medication that targets a group of proteins known as the tropomyosin receptor kinase (Trk) family, which includes TrkA, TrkB, and TrkC. These proteins are linked to genes called NTRK1, NTRK2, and NTRK3. When these genes fuse with others, they can lead to cancer growth. This study aims to see if TL118 can effectively treat patients with solid tumors that have these NTRK gene fusions.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older, any gender.
  • Have a confirmed diagnosis of a solid tumor that has spread or is locally advanced, with an NTRK gene fusion.
  • The cancer must have worsened during or after previous treatments, or the patient is not suitable for standard treatments.
  • Must not have been treated with TRK inhibitors before, except for a short period due to side effects.
  • Have at least one tumor that can be measured.
  • Be in relatively good health, with an ECOG score of 0, 1, or 2.
  • Have a life expectancy of more than 3 months.
  • Have adequate bone marrow, liver, kidney, and blood clotting function.

Exclusion Criteria

  • Have received chemotherapy, radiation, or other anti-cancer treatments recently (within 3 weeks for most treatments, 4 weeks for immunotherapy, and 2 weeks for certain other treatments).
  • Are participating in another clinical trial or have recently participated in one.
  • Have unresolved side effects from previous treatments that are more than mild.
  • Have active cancer spread to the brain.
  • Have had another primary cancer within the last 3 years, except for certain skin or cervical cancers.
  • Have an active infection that is not controlled.

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