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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: 06 Dec 2024

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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

    • 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.
    • 13 Jun 2024 According to a Bristol-Myers Squibb media release, company announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval of Augtyro™ (repotrectinib) for the treatment of adult and pediatric patients 12 years of age and older with solid tumors based on results from the Phase 1/2 TRIDENT-1 study.
    • 04 Jun 2024 Results assessing updated efficacy with a median follow-up of 33.9 months (mo) [~10 mo of additional follow-up], the first analyses of progression patterns, treatment beyond progression, and an update on subsequent anticancer therapies were presented at the 60th Annual Meeting of the American Society of Clinical Oncology.

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