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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)

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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: 08 May 2025

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At a glance

  • Drugs Repotrectinib (Primary) ; Midazolam
  • Indications Non-small cell lung cancer; Salivary gland cancer; Soft tissue sarcoma; Solid tumours; Thyroid cancer
  • Focus Adverse reactions; First in man; Registrational; Therapeutic Use
  • Acronyms TRIDENT-1
  • 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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