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

Description

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.

Conditions

Non Small Cell Lung Cancer, KRAS Activating Mutation

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Study Overview

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Study Details

Study overview

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.

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)

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

Condition
Non Small Cell Lung Cancer
Intervention / Treatment

-

Contacts and Locations

Boulder

Rocky Mountain Cancer Center, LLP, Boulder, Colorado, United States, 80303

Washington

Georgetown University Medical Center, Washington, District of Columbia, United States, 20007

Washington

MedStar Washington Hospital Center, MedStar Georgetown Cancer Institute,, Washington, District of Columbia, United States, 20010

Arlington Heights

Illinois Cancer Specialists, Arlington Heights, Illinois, United States, 60005

Rockville

Maryland Oncology & Hematology, P.A., Rockville, Maryland, United States, 20850

Boston

Dana Farber Cancer Institute, Boston, Massachusetts, United States, 02215

Detroit

Henry Ford Health System, Detroit, Michigan, United States, 48202

Woodbury

Minnesota Oncology Hematology, P.A, Woodbury, Minnesota, United States, 55125

Saint Louis

Washington University School of Medicine, Saint Louis, Missouri, United States, 63110

Cleveland

Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio, United States, 44195

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Male or female patients ≥ 18 years of age
  • * Histologic or cytologic evidence of NSCLC
  • * Known KRAS G12C mutation
  • * Have not received a KRAS inhibitor to be included in Part A (avutometinib + sotorasib) and Part B (avutometinib + sotorasib + defactinib), Cohort 1
  • * Received at least 1 dose of a G12C inhibitor to be included in Part A (avutometinib + sotorasib + defactinib) and Part B, Cohort 2
  • * 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Verastem, Inc.,

MD Verastem, STUDY_DIRECTOR, Verastem, Inc.

Study Record Dates

2027-04