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OncoMatch/Clinical Trials/NCT04094610

A Study of Repotrectinib in Pediatric and Young Adult Subjects Harboring ALK, ROS1, OR NTRK1-3 Alterations

Is NCT04094610 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies Oral repotrectinib (TPX-0005) for locally advanced solid tumors.

Phase 1/2RecruitingTurning Point Therapeutics, Inc.NCT04094610Data as of May 2026

Treatment: Oral repotrectinib (TPX-0005) — Phase 1 will evaluate the safety and tolerability at different dose levels of repotrectinib in pediatric and young adult subjects with advanced or metastatic malignancies harboring anaplastic lymphoma kinase (ALK), receptor tyrosine kinase encoded by the gene ROS1 (ROS1), or neurotrophic receptor kinase genes encoding TRK kinase family (NTRK1-3) alterations to estimate the Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) and select the Pediatric Recommended Phase 2 Dose (RP2D). Phase 2 will determine the anti-tumor activity of repotrectinib in pediatric and young adult subjects with advanced or metastatic malignancies harboring ROS1 or NTRK1-3 alterations.

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Extracted eligibility criteria

Cancer type

Tumor Agnostic

Non-Hodgkin Lymphoma

Biomarker criteria

Required: ROS1 point mutation, fusion, amplification

Documented genetic ROS1 point mutation, fusion, or amplification

Required: NTRK1 fusion

NTRK1-3 fusion

Required: NTRK2 fusion

NTRK1-3 fusion

Required: NTRK3 fusion

NTRK1-3 fusion

Lab requirements

Blood counts

Adequate hematologic function

Kidney function

Adequate renal function

Liver function

Adequate hepatic function

Adequate hematologic, renal and hepatic function

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Children's Hospital Los Angeles · Los Angeles, California
  • University of California at Los Angeles · Los Angeles, California
  • Children's Hospital Colorado - Anschutz Medical Campus · Aurora, Colorado
  • Local Institution - 2105 · Orlando, Florida
  • Local Institution - 2120 · Orlando, Florida

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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