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

Running, not enrolling · Phase 1/Phase 2

Conditions studied: Non Small Cell Lung Cancer, KRAS Activating Mutation

In brief

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.

Key facts

Study ID

NCT05074810

Run by

Verastem, Inc.

People needed

153

Starts

2022-04-12

Expected to finish

2027-04-01

Last updated by the study team

2026-01-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female patients ≥ 18 years of age
• Histologic or cytologic evidence of NSCLC
• Known KRAS G12C mutation
• Either exposed or not exposed to a KRAS inhibitor to be included in Part A (avutometinib + sotorasib + defactinib) and not exposed to KRAS inhibitor to be included in Part B (avutometinib + sotorasib + defactinib), Cohort 1
• Received at least 1 dose of a G12C inhibitor to be included in Part B, Cohort 2 (avutometinib + sotorasib + defactinib)
• Must have received appropriate treatment with at least one prior systemic regimen, but no more than 2 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

You may not qualify if…

• Systemic anti-cancer therapy within 4 weeks of the first dose of study therapy
• History of prior malignancy, with the exception of curatively treated malignancies
• Major surgery within 4 weeks, minor surgery within 2 weeks (excluding placement of vascular access)
• History of treatment with a direct and specific inhibitor of MEK
• Exposure to strong CYP3A4 inhibitors or inducers within 14 days prior to the first dose and during the course of therapy
• Symptomatic brain metastases requiring steroids or other local interventions.
• Known SARS-Cov2 infection ≤28 days prior to first dose of study therapy
• Known hepatitis B, hepatitis C, or human immunodeficiency virus infection that is active
• Active skin disorder that has required systemic therapy within the past year
• History of rhabdomyolysis
• Concurrent ocular disorders
• Concurrent heart disease or severe obstructive pulmonary disease
• Inability to swallow oral medications
• Female patients that are pregnant or breastfeeding
• Previously treated with sotorasib and were dose reduced due to toxicity

Where it is running

• Rocky Mountain Cancer Center, LLP — Boulder, Colorado, United States
• Georgetown University Medical Center — Washington D.C., District of Columbia, United States
• MedStar Washington Hospital Center, MedStar Georgetown Cancer Institute, — Washington D.C., District of Columbia, United States
• Illinois Cancer Specialists — Arlington Heights, Illinois, United States
• Maryland Oncology & Hematology, P.A. — Rockville, Maryland, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• Henry Ford Health System — Detroit, Michigan, United States
• Minnesota Oncology Hematology, P.A — Woodbury, Minnesota, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Cleveland Clinic Taussig Cancer Center — Cleveland, Ohio, United States
• Ohio State University Brain and Spine Hospital — Columbus, Ohio, United States
• Consultants in Medical Oncology & Hematology — Broomall, Pennsylvania, United States
• Alliance Cancer Specialists, — Horsham, Pennsylvania, United States
• Texas Oncology — Austin, Texas, United States
• University of Texas Southwestern Medical Center — Dallas, Texas, United States
• Texas Oncology - Fort Worth Cancer Center — Fort Worth, Texas, United States
• Texas Oncology — Longview, Texas, United States
• Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care — Blacksburg, Virginia, United States
• Virginia Cancer Specialists, PC — Fairfax, Virginia, United States
• Northwest Cancer Specialists — Vancouver, Washington, United States
• University Hospital Gent — Ghent, Belgium
• CHU de Liège — Liège, Belgium
• CHRU of Lille — Lille, France
• Hôpital Cochin — Paris, France
• Hôpital Foch — Suresnes, France

Full record on ClinicalTrials.gov

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