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Repotrectinib for Advanced Solid Tumors with ALK, ROS1, or NTRK Rearrangements

This study is testing an oral drug called repotrectinib (TPX-0005) for people with advanced solid tumors that have specific genetic changes (called ALK, ROS1, or NTRK1-3 rearrangements). These genetic changes are like markers that help doctors understand how a tumor might respond to certain treatments. The study aims to find the safest and most effective dose of repotrectinib and see how well it shrinks tumors. You could be eligible if you have a locally advanced or metastatic solid tumor with one of these genetic rearrangements and are at least 12 years old. The study is currently unclear on its recruitment status.

Study design
This is an interventional study with a planned enrollment of 500 participants. It is not specified if it is randomized or blinded.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The overall response rate will be measured 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.

NCT03093116

A Study of Repotrectinib (TPX-0005) in Patients With Advanced Solid Tumors Harboring ALK, ROS1, or NTRK1-3 Rearrangements

Recruiting
PHASE1Ages 12+InterventionalTreatment
Turning Point Therapeutics, Inc.
~500 participants
Updated 2026-05-27 on ClinicalTrials.gov
What's tested:Oral repotrectinib (TPX-0005)

At a glance

Recruiting sites
63 of 165 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

Explore related trials

Colorectal CarcinomaLung Non-Small Cell CarcinomaSarcomaSolid NeoplasmThyroid Gland CarcinomaALK GeneNTRK1 GeneNTRK2 GeneNTRK3 GeneROS1 Gene

Where it's being run

165 sites across 74 states
California8
China8
Spain8
France7
Italy7
South Korea6
Ohio5
Poland5

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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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Adequate tumor tissue must be sent to the Sponsor designated central diagnostic laboratory for prospective confirmation by a central diagnostic laboratory test selected by the Sponsor PRIOR to enrollment. 3. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1. 4. Age ≥12 (or age ≥ 20 as required by local regulation). 5. Willing and able to provide written institutional review board (IRB)/institutional ethics committee-approved Informed Consent or an Assent signed by a parent or legal guardian for subjects age 12 to 17. 6. At least 1 measurable target lesion according to RECIST (v1.1) prospectively confirmed by Blinded Independent Central Radiology Review (BICR), selected by Sponsor, PRIOR to enrollment. Subjects with CNS-only measurable disease ≥10 mm as defined by RECIST (v1.1) are eligible.

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)

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

    To determine the RP2D (Phase 1)

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

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