Phase 1/2 Study of Avutometinib (VS-6766) + Sotorasib With or Without Defactinib in KRAS G12C NSCLC Patients
NCT ID: NCT05074810
Last Updated: 2026-01-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1/PHASE2
153 participants
INTERVENTIONAL
2022-04-12
2027-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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avutometinib (VS-6766)+sotorasib
To determine the recommended phase 2 dose (RP2D) for avutometinib (VS 6766) in combination with sotorasib in KRAS G12C inhibitor naïve and exposed patients
avutometinib and sotorasib
The RP2D of avutometinib + sotorasib determined in Part A will be used in Part B dose expansion
avutometinib (VS-6766)+sotorasib - KRAS G12C inhibitor naïve
To determine the efficacy of the RP2D identified from Part A in KRAS G12C inhibitor naïve patients
avutometinib and sotorasib
The RP2D of avutometinib + sotorasib determined in Part A will be used in Part B dose expansion
avutometinib (VS-6766)+sotorasib - KRAS G12C inhibitor exposed
To determine the efficacy of the RP2D identified from Part A in KRAS G12C inhibitor exposed patients
avutometinib and sotorasib
The RP2D of avutometinib + sotorasib determined in Part A will be used in Part B dose expansion
avutometinib (VS-6766)+sotorasib+defactinib
To determine the recommended phase 2 dose (RP2D) for avutometinib (VS-6766) in combination with sotorasib and defactinib in KRAS G12C inhibitor exposed patients
avutometinib and sotorasib and defactinib
The RP2D of avutometinib + sotorasib + defactinib determined in Part A will be used in Part B dose expansion
avutometinib (VS-6766)+sotorasib+defactinib - KRAS G12C inhibitor naive
To determine the efficacy of the RP2D identified from Part A in KRAS G12C inhibitor naïve patients
avutometinib and sotorasib and defactinib
The RP2D of avutometinib + sotorasib + defactinib determined in Part A will be used in Part B dose expansion
avutometinib (VS-6766)+sotorasib+defactinib - KRAS G12C inhibitor exposed
To determine the efficacy of the RP2D identified from Part A in KRAS G12C inhibitor exposed patients
avutometinib and sotorasib and defactinib
The RP2D of avutometinib + sotorasib + defactinib determined in Part A will be used in Part B dose expansion
Interventions
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avutometinib and sotorasib
The RP2D of avutometinib + sotorasib determined in Part A will be used in Part B dose expansion
avutometinib and sotorasib and defactinib
The RP2D of avutometinib + sotorasib + defactinib determined in Part A will be used in Part B dose expansion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Verastem, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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MD Verastem
Role: STUDY_DIRECTOR
Verastem, Inc.
Locations
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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
Countries
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Other Identifiers
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VS-6766-203
Identifier Type: -
Identifier Source: org_study_id
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