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 (Jun 2026). This Phase 1/2 trial studies Oral repotrectinib (TPX-0005) for locally advanced solid tumors.
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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Tumor Agnostic
Non-Hodgkin Lymphoma
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
Demographics
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 →Frequently asked questions
Is NCT04094610 currently recruiting?
Yes, this trial is currently recruiting patients.
Does this trial require ROS1?
Yes, ROS1 point mutation, fusion, amplification is a required biomarker for enrollment.
Does this trial require NTRK1?
Yes, NTRK1 fusion is a required biomarker for enrollment.
Does this trial require NTRK2?
Yes, NTRK2 fusion is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 25 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify