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A Phase 1b and 2a Study to Assess Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of PLX9486 as a Single Agent and in Combination With PLX3397 or Sunitinib (Sutent) in Patients With Advanced Solid Tumors and Patients With Locally Advanced, Unresectable, or Metastatic Gastrointestinal Stromal Tumor (GIST) Who Have Been Previously Treated With Imatinib Mesylate/KIT-Directed Tyrosine Kinase Inhibitor (TKI) Therapy

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Trial Profile

A Phase 1b and 2a Study to Assess Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of PLX9486 as a Single Agent and in Combination With PLX3397 or Sunitinib (Sutent) in Patients With Advanced Solid Tumors and Patients With Locally Advanced, Unresectable, or Metastatic Gastrointestinal Stromal Tumor (GIST) Who Have Been Previously Treated With Imatinib Mesylate/KIT-Directed Tyrosine Kinase Inhibitor (TKI) Therapy

Status: Completed
Phase of Trial: Phase I/II

Latest Information Update: 20 Feb 2025

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At a glance

  • Drugs Bezuclastinib (Primary) ; Pexidartinib (Primary) ; Sunitinib (Primary)
  • Indications Gastrointestinal stromal tumours; Solid tumours
  • Focus Adverse reactions; Pharmacokinetics
  • Sponsors Cogent Biosciences; Plexxikon

Most Recent Events

  • 14 Feb 2025 According to ClinicalTrials.gov by the U.S. National Institutes of Health, the primary endpoints have been replaced from 12 to 10 endpoints.
  • 18 Nov 2020 Final results from this study for PLX9486 + Sunitinib combination (n=18), presented in a Cogent Biosciences media release.
  • 05 Oct 2020 According to an Unum Therapeutics media release, detailed results of this study will be presented as an oral presentation at the upcoming 2020 CTOS Annual Meeting.

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