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FRAME: A Phase I Trial of the Combination of Defactinib (VS-6063) (FAK Inhibitor) and VS-6766 (RO5126766) (CH5126776) (a Dual RAF/MEK Inhibitor) in Patients With Advanced Solid Tumours

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Trial Profile

FRAME: A Phase I Trial of the Combination of Defactinib (VS-6063) (FAK Inhibitor) and VS-6766 (RO5126766) (CH5126776) (a Dual RAF/MEK Inhibitor) in Patients With Advanced Solid Tumours

Status: Active, no longer recruiting
Phase of Trial: Phase I

Latest Information Update: 03 Apr 2025

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At a glance

  • Drugs Avutometinib (Primary) ; Defactinib (Primary)
  • Indications Colorectal cancer; Endometrial cancer; Non-small cell lung cancer; Ovarian cancer; Pancreatic cancer; Solid tumours
  • Focus Adverse reactions; Proof of concept
  • Acronyms FRAME

Most Recent Events

  • 20 Mar 2025 According to a Verastem Oncology media release, the U.S. Food and Drug Administration (FDA) accepted the Companys New Drug Application (NDA) under the accelerated approval pathway and granted Priority Review for avutometinib in combination with defactinib in adult patients with KRAS mutant recurrent LGSOC and designated June 30, 2025, as the Prescription Drug User Fee Act (PDUFA) action date.
  • 23 Jan 2025 According to a Verastem Oncology media release, primary analysis from FRAME clinical trial will be published in H1 2025.
  • 31 Oct 2024 According to a Verastem Oncology media release, FDA filing decision for accelerated approval and priority review of its NDA submission in patients with KRAS mutant low-grade serous ovarian cancer, is expected before the end of 2024 with potential for FDA approval decision by mid-2025. It also includes supportive data from the FRAME Phase 1 trial, the first study conducted with the combination in recurrent LGSOC.

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