Study on Repotrectinib for Children and Young Adults with Specific Genetic Changes in Cancer

Sponsor: Turning Point Therapeutics, Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04094610

Provider View

This clinical trial is testing the safety and effectiveness of a drug called repotrectinib in children and young adults with advanced cancers that have specific genetic changes. The study aims to find the best dose and see how well the drug works against tumors.

Patient Parameters

Program Overview

The study is divided into two phases. Phase 1 will test different doses of repotrectinib to find the safest and most effective dose for children and young adults with advanced cancers that have specific genetic changes (ALK, ROS1, or NTRK1-3). Phase 2 will evaluate how well repotrectinib works in shrinking tumors in young patients with these genetic changes.

Description

In Phase 1, children under 12 years old with advanced or metastatic solid tumors, including brain tumors or a type of lymphoma called anaplastic large cell lymphoma (ALCL), will be enrolled to determine the best dose of repotrectinib for this age group. Once the dose is determined, these children may continue to Phase 2.

In Phase 2, young people aged 12 to 25 will be enrolled directly. Participants will be divided into three groups based on their specific genetic changes:

  • Cohort 1: 10-20 participants with solid tumors that have NTRK fusion and have not been treated with TRK inhibitors.
  • Cohort 2: 23 participants with solid tumors that have NTRK fusion and have been treated with TRK inhibitors before.
  • Cohort 3: 20 participants with solid tumors or ALCL with other ALK/ROS1/NTRK changes or NTRK fusions, focusing on those with ROS1 changes.

The study will assess the safety and effectiveness of repotrectinib in these groups.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed genetic change in ROS1 or NTRK1-3, identified by a certified lab.
  • Phase 1: Under 12 years old; Phase 2: 12 to 25 years old.
  • Previous chemotherapy and immunotherapy are allowed.
  • Must have recovered from any side effects of previous cancer treatments.
  • Must have measurable disease based on specific medical criteria.
  • If there is a brain tumor or metastasis, it must be stable with no increase in steroid medication for at least 7 days before joining the study.
  • Must have a performance score indicating they can perform daily activities.
  • Must have a life expectancy of at least 12 weeks.
  • Must have adequate blood, kidney, and liver function.

Phase 2 Specific Criteria:

  • Cohort 1: Have NTRK fusion positive tumors and have not been treated with TRK inhibitors.
  • Cohort 2: Have NTRK fusion positive tumors and have been treated with TRK inhibitors.
  • Cohort 3: Have tumors with ROS1 changes and measurable disease.

Exclusion Criteria

  • Have neuroblastoma with only bone marrow disease.
  • Have had major surgery within 14 days before starting the study drug.
  • Have active infections requiring treatment.
  • Have digestive diseases that affect drug absorption.
  • Have heart conditions that affect the heart's electrical activity.
  • Have severe nerve damage.
  • Are taking or need to take certain medications that affect how the body processes drugs.
  • Have allergies to repotrectinib or its ingredients.

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