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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: 30 Sep 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

    • 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.
    • 03 Jun 2024 According to a Bristol-Myers Squibb media release, data from this study presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting from May 31 to June 4, 2024, in Chicago, IL.

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