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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: 29 Jul 2020

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At a glance

  • Drugs Repotrectinib (Primary) ; Midazolam
  • Indications CNS cancer; 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

    • 07 Jul 2020 According to a Turning Point Therapeutics media release, Zai Lab anticipates opening additional sites in Greater china ( which includes mainland China, Hong Kong, Macau and Taiwan) for this trial.
    • 31 May 2020 Trial design presented at the 56th Annual Meeting of the American Society of Clinical Oncology
    • 12 May 2020 According to a Turning Point Therapeutics media release, Early interim data from initial patients in the TRIDENT-1 Phase 2 study during the second half of the year. The company anticipates this update will include preliminary efficacy and safety data from approximately 30 to 40 patients across multiple Phase 2 cohorts, including registrational and exploratory cohorts.
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