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
Location: See all (8) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Male or female subjects ≥ 18 years of age

• Histologic or cytologic evidence of NSCLC

• Known KRAS G12C mutation

• The subject must have received prior therapy with a KRAS G12C inhibitor and experienced progression

• Must have received appropriate treatment with at least one prior systemic regimen, but no more than 3 prior regimens, for Stage 3B-C or 4 NSCLC

• Measurable disease according to RECIST 1.1

• An Eastern Cooperative Group (ECOG) performance status ≤ 1

• Adequate organ function

• Adequate recovery from toxicities related to prior treatments

• Agreement to use highly effective method of contraceptive

Locations
United States
California
UCSF Thoracic Oncology
San Francisco
Colorado
University of Colorado Hospital Anschutz Cancer Pavllion
Aurora
Florida
Mayo Clinic Cancer Center
Jacksonville
Minnesota
Mayo Clinic Cancer Center
Rochester
North Carolina
University of North Carolina at Chapel Hill
Chapel Hill
New York
Memorial Sloan Kettering Cancer Center
New York
Virginia
Virginia Cancer Specialists, NEXT Oncology
Fairfax
Wisconsin
Medical College Wisconsin
Milwaukee
Time Frame
Start Date: 2022-08-01
Completion Date: 2026-01-01
Participants
Target number of participants: 85
Treatments
Experimental: avutometinib(VS-6766)+adagrasib
To determine the recommended phase 2 dose (RP2D) for VS-6766 in combination with adagrasib in G12C inhibitor exposed patients
Experimental: avutometinib (VS-6766)+adagrasib RP2D
To determine the efficacy of the RP2D identified from Part A in G12C inhibitor exposed patients
Sponsors
Collaborators: Mirati Therapeutics Inc.
Leads: Verastem, Inc.

This content was sourced from clinicaltrials.gov