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A Phase 1/2, Open-Label, Multi-Center, First-in-Human Study of the Safety, Tolerability, Pharmacokinetics, and Anti-Tumor Activity of TPX-0005 in Patients With Advanced Solid Tumors Harboring ALK, ROS1, or NTRK1-3 Rearrangements (TRIDENT-1)

Trial Profile

A Phase 1/2, Open-Label, Multi-Center, First-in-Human Study of the Safety, Tolerability, Pharmacokinetics, and Anti-Tumor Activity of TPX-0005 in Patients With Advanced Solid Tumors Harboring ALK, ROS1, or NTRK1-3 Rearrangements (TRIDENT-1)

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 04 Dec 2019

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At a glance

  • Drugs Repotrectinib (Primary)
  • Indications CNS cancer; Nervous system neoplasms; Non-small cell lung cancer; Solid tumours
  • Focus Adverse reactions; First in man; Registrational; Therapeutic Use
  • Acronyms TRIDENT-1
  • Sponsors Turning Point Therapeutics
  • Most Recent Events

    • 03 Sep 2019 Updated interim data as of (July 22, 2019), from phase I portion of the trial, presented in a Turning Point Therapeutics media release.
    • 06 Aug 2019 According to a Turning Point Therapeutics media release, updated data from the study will be presented at the European Society for Medical Oncology (ESMO) conference 2019.
    • 06 Aug 2019 According to a Turning Point Therapeutics media release, the U.S. Food and Drug Administration (FDA) has accepted the company's recommended Phase 2 dose regimen for Repotrectinib in the trial. The regimen will dose patients at 160 mg daily for the first 14 days, after which the dose may be increased to 160 mg twice daily based on patient tolerability.
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