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

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

Trial Details

NCT ID
NCT04094610
Phase
PHASE1 / PHASE2
Sponsor
Turning Point Therapeutics, Inc.
Status
RECRUITING
Cancer Type
Non-Hodgkin Lymphoma Lymphoma
Interventions
  • Oral repotrectinib (TPX-0005)
Locations (sample)
  • Los Angeles, California, United States|34.05223,-118.24368
  • Los Angeles, California, United States|34.05223,-118.24368
  • Aurora, Colorado, United States|39.72943,-104.83192
  • Orlando, Florida, United States|28.53834,-81.37924
  • Orlando, Florida, United States|28.53834,-81.37924

Key Eligibility Criteria

  • Documented genetic ROS1 point mutation, fusion, or amplification or NTRK1-3 fusion as identified by local testing in a Clinical Laboratory Improvem…
  • Phase 1: Age \<12 years; Phase 2: Age 12- 25 years
  • Prior cytotoxic chemotherapy is allowed.
  • Prior immunotherapy is allowed.

For full eligibility, visit ClinicalTrials.gov.

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