NCT05074810

Phase 1/2 Study of Avutometinib (VS-6766) + Sotorasib With or Without Defactinib in KRAS G12C NSCLC Patients

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)

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 153 (estimated)
• Sponsor: Verastem, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This is a multicenter, non-randomized, open-label Phase 1/2 study designed to evaluate safety and tolerability and efficacy of avutometinib (VS-6766) in combination with sotorasib with or without defactinib in patients with KRAS G12C mutant NSCLC.

Conditions

• Non Small Cell Lung Cancer
• KRAS Activating Mutation

Interventions

Type	Name	Description
DRUG	avutometinib and sotorasib	The RP2D of avutometinib + sotorasib determined in Part A will be used in Part B dose expansion
DRUG	avutometinib and sotorasib and defactinib	The RP2D of avutometinib + sotorasib + defactinib determined in Part A will be used in Part B dose expansion

Timeline

• Start date: 2022-04-12
• Primary completion: 2026-06-01
• Completion: 2027-04-01
• First posted: 2021-10-12
• Last updated: 2026-01-12

Locations

35 sites across 6 countries: United States, Belgium, France, Netherlands, Spain, United Kingdom

Regulatory

• FDA-regulated drug study