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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: 30 Apr 2026

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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

  • 01 Apr 2026 According to a Fore Biotherapeutics media release, based on NCT02428712 phase I/IIa trial and NCT05503797 phase II basket trial the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to plixorafenib for the treatment of adult patients with BRAF V600E-mutated high-grade glioma (HGG).
  • 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.

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