A Study of Repotrectinib in Pediatric and Young Adult Subjects Harboring ALK, ROS1, OR NTRK1-3 Alterations
Recruiting now · Phase 1/Phase 2
Conditions studied: Locally Advanced Solid Tumors, Metastatic Solid Tumors, Lymphoma, Primary CNS Tumors
In brief
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.
Key facts
- Study ID
- NCT04094610
- Run by
- Turning Point Therapeutics, Inc.
- People needed
- 75
- Starts
- 2020-03-12
- Expected to finish
- 2027-09-30
- Last updated by the study team
- 2025-11-19
Who can join
Age: any, up to 25. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Centre Hospitalier Universitaire de Bordeaux - Groupe Hospitalier Pellegrin — Bordeaux, France (enrolling)
- Hôpitaux Universitaires de Marseille Timone — Marseille, France (enrolling)
- Stollery Children'S Hospital — Edmonton, Alberta, Canada (enrolling)
- Centre Hospitalier Universitaire D'Angers — Angers, France (enrolling)
- Children's Hospital Colorado - Anschutz Medical Campus — Aurora, Colorado, United States (enrolling)
- Institut d Hematologie et d Oncologie Pediatriques — Lyon, France (enrolling)
- Dana Farber Cancer Institute. — Boston, Massachusetts, United States (enrolling)
- University of California at Los Angeles — Los Angeles, California, United States (enrolling)
- Children'S Hospital Of Eastern Ontario — Ottawa, Ontario, Canada (enrolling)
- Rigshospitalet - Glostrup — Copenhagen, Denmark (enrolling)
- Levine Children's Hospital- Pediatric Neuro-Oncology — Charlotte, North Carolina, United States (enrolling)
- Children's Healthcare of Atlanta - Egleston Hospital — Atlanta, Georgia, United States (enrolling)
- Maine Medical Center — Scarborough, Maine, United States (enrolling)
- Children's Hospital of Philadelphia-Center for Childhood Cancer Research — Philadelphia, Pennsylvania, United States (enrolling)
- St. Jude Children's Research Hospital — Memphis, Tennessee, United States (enrolling)
- The University of Texas Southwestern Medical Center - Harold C Simmons Comprehensive Cancer Center — Dallas, Texas, United States (enrolling)
- Baylor College of Medicine — Houston, Texas, United States (enrolling)
- Washington University School of Medicine in St. Louis — St Louis, Missouri, United States (enrolling)
- Children's Hospital Los Angeles — Los Angeles, California, United States (enrolling)
- Local Institution - 6104 — Randwick, New South Wales, Australia (enrolling)
- St Justine Hospital — Montreal, Quebec, Canada (enrolling)
- Children's Health Queensland Hospital and Health Service — South Brisbane, Queensland, Australia (enrolling)
- Perth Childrens Hospital — Nedlands, Western Australia, Australia (enrolling)
- University Of Calgary — Calgary, Alberta, Canada (enrolling)
- Institut Gustave-Roussy — Villejuif, France (enrolling)
Full record on ClinicalTrials.gov
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