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Repotrectinib for ALK, ROS1, or NTRK Alterations in Pediatric and Young Adults

This study is testing an oral drug called repotrectinib (TPX-0005) in children and young adults up to 25 years old who have advanced or metastatic solid tumors, lymphoma, or primary brain tumors. These tumors must have specific genetic changes (called ALK, ROS1, or NTRK1-3 alterations). Repotrectinib works by blocking certain proteins (kinase and tyrosine kinase inhibitors) that can help cancer grow. The study aims to find a safe and effective dose for younger patients and see how well repotrectinib shrinks tumors. Success will be measured by how many patients respond to the treatment. The study plans to enroll about 75 participants, but its current status is unclear.

Study design
This is an interventional study with two phases. Phase 1 will determine the best dose, while Phase 2 will assess the drug's effectiveness. It plans to enroll about 75 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will measure overall response rate two to three years after the first dose of repotrectinib.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04094610

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

Recruiting
PHASE1Up to 25InterventionalTreatment
Turning Point Therapeutics, Inc.
~75 participants
Updated 2026-09-04 on ClinicalTrials.gov
What's tested:Oral repotrectinib (TPX-0005)

At a glance

Recruiting sites
44 of 68 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Dose limiting toxicities (DLTs) (Phase 1)
Measured over Within 28 days of the first repotrectinib dose
+2 more outcomes measured

Conditions

Locally Advanced Solid Tumors
Metastatic Solid Tumors
Lymphoma
Primary CNS Tumors

Explore related trials

LymphomaNew Primary TumorSolid NeoplasmNTRK1-3ROS1 Gene

NCT04094610

Where you'd take part

This study runs at 68 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Alder Hey Children's NHS Foundation Trust

    Liverpool, England, United Kingdomstudy coordinator listed

    Recruiting

  • Asan Medical Center

    Seoul, South Koreastudy coordinator listed

    Recruiting

  • Centre Hospitalier Universitaire D'Angers

    Angers, Francestudy coordinator listed

    Recruiting

  • Centre Hospitalier Universitaire de Bordeaux - Groupe Hospitalier Pellegrin

    Bordeaux, Francestudy coordinator listed

    Recruiting

  • Children's Health Queensland Hospital and Health Service

    South Brisbane, Queensland, Australiastudy coordinator listed

    Recruiting

  • Children's Healthcare of Atlanta - Egleston Hospital

    Atlanta, Georgiastudy coordinator listed

    Recruiting

  • Children's Hospital Colorado - Anschutz Medical Campus

    Aurora, Coloradostudy coordinator listed

    Recruiting

  • Children's Hospital Los Angeles

    Los Angeles, Californiastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Bristol-Myers Squibb · STUDY_DIRECTOR · Bristol-Myers Squibb

Who to contact

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
[email protected]
855-907-3286
Email the study team

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Eligibility criteria

Inclusion

Cohort 1: Subjects with NTRK fusion gene positive (NTRK+) advanced solid tumors (including primary CNS tumors), that are tropomyosin receptor kinase (TRK) TKI naïve;
Cohort 2: subjects with NTRK+ advanced solid tumors (including primary CNS tumors), that are TRK TKI pre-treated;
Cohort 3: subjects with advanced solid tumors with ROS1 gene fusions or other ROS1 aberrations (including amplifications and point mutations) with measurable disease. 2. Subjects in Cohorts 1 and 2 must have prospectively confirmed measurable disease by BICR prior to enrollment.

Exclusion

Mean resting corrected QT interval (ECG interval measured from the onset of the QRS complex to the end of the T wave) for heart rate (QTc) \> 480 msec obtained from three ECGs, using the screening clinic ECG machine-derived QTc value
Any clinically important abnormalities in rhythm, conduction, or morphology of resting ECG (e.g., complete left bundle branch block, third degree heart block, second degree heart block, PR interval \> 250 msec)
Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, congenital long QT syndrome, family history of long QT syndrome, or any concomitant medication known to prolong the QT interval 6. Peripheral neuropathy of CTCAE ≥grade 2. 7. Subjects being treated with or anticipating the need for treatment with strong CYP3A4 inhibitors or inducers. 8. Any potential allergies to repotrectinib and/or its excipients.

What this trial measures

  • Dose limiting toxicities (DLTs) (Phase 1)Within 28 days of the first repotrectinib dose

    Define the dose limiting toxicities (DLTs) (Phase 1)

  • Pediatric Recommended Phase 2 Dose (RP2D) (Phase 1)Within 28 days of the last patient dosed in escalation

    To determine the pediatric RP2D (Phase 1)

  • Overall Response Rate (ORR) (Phase 2)Two to three years after first dose of repotrectinib

    To determine the confirmed ORR of repotrectinib (TPX-0005) as assessed by Blinded Independent Central Review (Phase 2)