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A Phase 1b, Open-Label, Dose-escalation and Expansion Study to Investigate the Safety, Pharmacokinetics and Antitumor Activities of a RAF Dimer Inhibitor BGB-283 in Combination With MEK Inhibitor PD-0325901 in Patients With Advanced or Refractory Solid Tumors

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Trial Profile

A Phase 1b, Open-Label, Dose-escalation and Expansion Study to Investigate the Safety, Pharmacokinetics and Antitumor Activities of a RAF Dimer Inhibitor BGB-283 in Combination With MEK Inhibitor PD-0325901 in Patients With Advanced or Refractory Solid Tumors

Status: Recruiting
Phase of Trial: Phase I

Latest Information Update: 08 Jun 2023

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At a glance

  • Drugs Lifirafenib (Primary) ; Mirdametinib (Primary)
  • Indications Colorectal cancer; Endometrial cancer; Malignant melanoma; Non-small cell lung cancer; Ovarian cancer; Pancreatic cancer; Solid tumours; Thyroid cancer
  • Focus Adverse reactions; First in man; Therapeutic Use
  • Sponsors BeiGene

    • Most Recent Events

    • 05 Jun 2023 Phase of the trial is changed from phase 1/2 to phase 1. Number of treatment arms have been reduced from 4 to 2, by the removal of Experimental: Part B: Group 1 and Experimental: Part B: Group 3 arms.
    • 05 Jun 2023 Planned End Date changed from 29 Apr 2024 to 28 Feb 2026.
    • 05 Jun 2023 Planned primary completion date changed from 30 Mar 2024 to 30 Sep 2025.
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