Clinical Trial

Phase I Trial of Defactinib and VS-6766.

Study acronym: FRAME
Active, Not Recruiting Phase 1
View on ClinicalTrials.gov →
Summary
This is a multi-centre, investigator-initiated, dose escalation, Phase I trial of the combination of the FAK inhibitor, Defactinib (VS-6063), and the dual RAF/MEK inhibitor, VS-6766 (RO5126766) in patients with advanced solid tumours. VS-6766 (RO5126766) is the same compound as CH5126766. There are two parts to this study, the dose escalation phase and the dose expansion phase. In the dose escalation phase, cohorts of 3 to 6 patients will be enrolled to determine the maximum tolerated dose (MTD) and recommended Phase II dose (RP2D). This will be followed by a dose expansion phase to further characterise the safety and tolerability and to assess the pharmacodynamic activity of the combination.
Protocol Amendment History 9 amendments
This ClinicalTrials.gov record has been amended 9 times since 2019-03-12; most recent amendment 2026-03-08.
Status change: Recruiting → Active, Not Recruiting 2023-07-07
Status change: Active, Not Recruiting → Recruiting 2020-06-24
Status change: Recruiting → Active, Not Recruiting 2020-04-08
Trial Details
NCT Number NCT03875820
Lead Sponsor Institute of Cancer Research, United Kingdom
Collaborators: Verastem, Inc.
Conditions NSCLC, Low Grade Serous Ovarian Cancer, Endometrioid Carcinoma, Pancreatic Cancer
Enrollment 87 participants
Start Date 2017-12-12
Primary Completion 2023-04-30 (estimated)
Study Completion 2026-10-31 (estimated)
Updated on ClinicalTrials.gov 2026-03-10