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ACTIVE NOT RECRUITING
NCT05074810
PHASE1/PHASE2

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

Sponsor: Verastem, Inc.

View on ClinicalTrials.gov

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.

Official title: 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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

153

Start Date

2022-04-12

Completion Date

2027-04

Last Updated

2026-01-12

Healthy Volunteers

No

Interventions

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

Locations (35)

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

Leids Universitair Medisch Centrum

Leiden, Netherlands

Erasmus MC

Rotterdam, Netherlands

Hospital Teresa Herrera (C.H.U.A.C)

A Coruña, Spain

Hospital General Universitario Gregorio Marañón

Madrid, Spain

Hospital Universitario Fundación Jiménez Díaz

Madrid, Spain

Hospital Universitario Virgen De La Victoria

Málaga, Spain

Hospital Universitario Virgen de la Macarena

Seville, Spain

University of Leicester

Leicester, United Kingdom

Royal Marsden Hospital

London, United Kingdom

Royal Marsden Hospital

Sutton, United Kingdom