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A Phase 1/2, Open-Label, Safety, Tolerability, Pharmacokinetics, and Anti-Tumor Activity Study of Repotrectinib in Pediatric and Young Adult Subjects With Advanced or Metastatic Malignancies Harboring ALK, ROS1, NTRK1-3 Alterations

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Trial Profile

A Phase 1/2, Open-Label, Safety, Tolerability, Pharmacokinetics, and Anti-Tumor Activity Study of Repotrectinib in Pediatric and Young Adult Subjects With Advanced or Metastatic Malignancies Harboring ALK, ROS1, NTRK1-3 Alterations

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 12 Mar 2025

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At a glance

  • Drugs Repotrectinib (Primary)
  • Indications Anaplastic large cell lymphoma; Cancer metastases; CNS cancer; Solid tumours
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms CARE
  • Sponsors Turning Point Therapeutics

Most Recent Events

  • 27 Feb 2025 According to ZAI Lab media release, the company plans to submit supplementary NDA to the NMPA in NTRK+ solid tumors in the first half of 2025.
  • 06 Feb 2025 According to a Bristol-Myers Squibb media release, company announced that the EC approved Augtyro , a next-generation tyrosine kinase inhibitor (TKI), as a treatment for adult patients with ROS1-positive advanced non-small cell lung cancer and for the treatment of adult and pediatric patients 12 years of age and older. The approval is based on results from the TRIDENT-1 and CARE trials.
  • 15 Nov 2024 According to a Bristol-Myers Squibb media release, company announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval for repotrectinib, as a treatment for adult patients with ROS1-positive advanced non-small cell lung cancer and for the treatment of adult and pediatric patients 12 years of age and older with advanced solid tumors this positive opinion is based on results from the TRIDENT-1 and CARE trials.

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