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A Phase 1/2a Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of FORE8394 in Patients With Advanced Unresectable Solid Tumors

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Trial Profile

A Phase 1/2a Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of FORE8394 in Patients With Advanced Unresectable Solid Tumors

Status: Completed
Phase of Trial: Phase I/II

Latest Information Update: 09 Nov 2025

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At a glance

  • Drugs Plixorafenib (Primary) ; Cobicistat
  • Indications Anaplastic thyroid carcinoma; Colorectal cancer; Glioma; Malignant melanoma; Neuroendocrine tumours; Ovarian cancer; Solid tumours; Thyroid cancer
  • Focus Adverse reactions; Pharmacokinetics; Registrational; Therapeutic Use
  • Sponsors Novellus Biopharma; Plexxikon

Most Recent Events

  • 24 Sep 2025 According to a Fore Biotherapeutics media release, Macarena de la Fuente, M.D., Chief of Neuro-Oncology at the University of Miami Sylvester Comprehensive Cancer Center is the lead CNS Investigator for this trial.
  • 12 Sep 2025 According to Fore Biotherapeutics media release, results from 21 patients with thyroid cancer, 16 with PTC and 5 with ATC, treated with plixorafenib in a previously completed Phase 1/2a study are presented at the American Thyroid Association (ATA) 2025 Annual Meeting, taking place September 10-14, 2025 in Scottsdale.
  • 30 Apr 2025 Results (n=71) from the the analysis of longitudinal ctDNA from plixorafenib-treated pts, an exploratory endpoint from this Phase 1/2a study presented at the 116th Annual Meeting of the American Association for Cancer Research.

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