Study of Avutometinib (VS-6766) + Adagrasib in KRAS G12C NSCLC Patients

Part of paid clinical trials in San Francisco, California.

Sponsor
Verastem, Inc.
Study ID
NCT05375994
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

  • Advanced Cancer
  • KRAS Activating Mutation
  • Malignant Neoplasm of Lung
  • Malignant Neoplastic Disease
  • Metastatic Cancer
  • Non Small Cell Lung Cancer

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 adagrasib in patients with G12C Non-Small Cell Lung Cancer (NSCLC) who have been exposed to prior G12C inhibitor and experienced progressive disease.

Key Dates

Start date
Aug 1, 2022
Status verified
May 2025
Primary completion
Dec 24, 2025
Completion
Jan 1, 2026

Study Design

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

Arms

  • 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

Primary Outcome Measure

Part A: To determine RP2D for avutometinib(VS-6766) in combination with adagrasib [ Time Frame: From start of treatment to confirmation of RP2D; 28 days ]

Locations (8)

FacilityCityStateZIPSite coordinators
UCSF Thoracic OncologySan FranciscoCalifornia94158-
University of Colorado Hospital Anschutz Cancer PavllionAuroraColorado80045-
Mayo Clinic Cancer CenterJacksonvilleFlorida32224-
Mayo Clinic Cancer CenterRochesterMinnesota55905-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
University of North Carolina at Chapel HillChapel HillNorth Carolina275514-
Virginia Cancer Specialists, NEXT OncologyFairfaxVirginia22031-
Medical College WisconsinMilwaukeeWisconsin53226-

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