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

Part of paid clinical trials in Boulder, Colorado.

Sponsor
Verastem, Inc.
Study ID
NCT05074810
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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 Dates

Start date
Apr 12, 2022
Status verified
Jan 2026
Primary completion
Jun 30, 2026
Completion
Apr 30, 2027

Study Design

Enrollment
153 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: 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
  • Experimental: 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
  • Experimental: 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
  • Experimental: 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
  • Experimental: 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
  • Experimental: 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

Primary Outcome Measure

Part A: To determine RP2D for avutometinib in combination with sotorasib and the Alt-RP2D for avutometinib in combination with sotorasib and defactinib [ Time Frame: From start of treatment to confirmation of RP2D; 28 days ]

Locations (20)

FacilityCityStateZIPSite coordinators
Rocky Mountain Cancer Center, LLPBoulderColorado80303-
Georgetown University Medical CenterWashington D.C.District of Columbia20007-
MedStar Washington Hospital Center, MedStar Georgetown Cancer Institute,Washington D.C.District of Columbia20010-
Illinois Cancer SpecialistsArlington HeightsIllinois60005-
Maryland Oncology & Hematology, P.A.RockvilleMaryland20850-
Dana Farber Cancer InstituteBostonMassachusetts02215-
Henry Ford Health SystemDetroitMichigan48202-
Minnesota Oncology Hematology, P.AWoodburyMinnesota55125-
Washington University School of MedicineSt LouisMissouri63110-
Cleveland Clinic Taussig Cancer CenterClevelandOhio44195-
Ohio State University Brain and Spine HospitalColumbusOhio43210-
Consultants in Medical Oncology & HematologyBroomallPennsylvania19008-
Alliance Cancer Specialists,HorshamPennsylvania19044-
Texas OncologyAustinTexas78731-
University of Texas Southwestern Medical CenterDallasTexas75390-
Texas Oncology - Fort Worth Cancer CenterFort WorthTexas76104-
Texas OncologyLongviewTexas75601-
Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer CareBlacksburgVirginia24060-
Virginia Cancer Specialists, PCFairfaxVirginia22031-
Northwest Cancer SpecialistsVancouverWashington98684-

Find similar trials in Boulder, CO

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
Rocky Mountain Cancer Center, LLP· Boulder, COGeorgetown University Medical Center· Washington D.C., DCMedStar Washington Hospital Center, MedStar Georgetown Cancer Institute· Washington D.C., DCIllinois Cancer Specialists· Arlington Heights, ILMaryland Oncology & Hematology, P.A.· Rockville, MDDana Farber Cancer Institute· Boston, MA

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