NCT05375994

Study of Avutometinib (VS-6766) + Adagrasib in KRAS G12C NSCLC Patients

A Phase 1/2 Study of Avutometinib (VS-6766) in Combination With Adagrasib in Patients With KRAS G12C Mutant Non-Small Cell Lung Cancer (NSCLC) (RAMP 204)

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 85 (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 adagrasib in patients with G12C Non-Small Cell Lung Cancer (NSCLC) who have been exposed to prior G12C inhibitor and experienced progressive disease.

Detailed description

This is a multicenter, non-randomized, open-label Phase 1/2 study designed to evaluate safety, tolerability and efficacy of avutometinib (VS-6766) in combination with adagrasib in patients with KRAS G12C mutant NSCLC who have been exposed to prior G12C inhibitor and experienced progressive disease.

Conditions

• Non Small Cell Lung Cancer
• KRAS Activating Mutation
• Advanced Cancer
• Metastatic Cancer
• Malignant Neoplasm of Lung
• Malignant Neoplastic Disease

Interventions

Type	Name	Description
DRUG	avutometinib (VS-6766) and adagrasib	The RP2D of VS-6766 + adagrasib determined in Part A will be used in Part B dose expansion

Timeline

• Start date: 2022-08-01
• Primary completion: 2025-12-24
• Completion: 2026-01-01
• First posted: 2022-05-17
• Last updated: 2025-05-18

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated drug study