A Phase 1/2 Study of Avutometinib (VS-6766) in Combination With Sotorasib With or Without Defactinib in Patients With KRAS G12C Mutant Non-Small Cell Lung Cancer (NSCLC) (RAMP203)

NCT05074810 Phase 1/Phase 2 ACTIVE_NOT_RECRUITING

This study will assess the safety and efficacy of avutometinib (VS-6766) in combination with sotorasib with or without defactinib in patients with KRAS G12C Non-Small Cell Lung Cancer (NSCLC) in patients who have been exposed to prior G12C inhibitor and those who have not been exposed to prior G12C inhibitor.

Details

Lead sponsor	Verastem, Inc.
Phase	Phase 1/Phase 2
Status	ACTIVE_NOT_RECRUITING
Enrolment	153
Start date	2022-04-12
Completion	2027-04

Conditions

• Non Small Cell Lung Cancer
• KRAS Activating Mutation

Interventions

• avutometinib and sotorasib
• avutometinib and sotorasib and defactinib

Primary outcomes

• Part A: To determine RP2D for avutometinib in combination with sotorasib and the Alt-RP2D for avutometinib in combination with sotorasib and defactinib — From start of treatment to confirmation of RP2D; 28 days
  Assessment of Dose-limiting toxicities (DLTs)
• Part B: To determine the efficacy of the RP2D and/or Alt-RP2D identified from Part A — From start of treatment to confirmation of response; 16 weeks
  Confirmed overall response rate per RECIST 1.1

Countries

United States, Belgium, France, Netherlands, Spain, United Kingdom