Study of Avutometinib (VS-6766) + Adagrasib in KRAS G12C NSCLC Patients
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.
Conditions:
🦠 Non Small Cell Lung Cancer 🦠 KRAS Activating Mutation 🦠 Advanced Cancer 🦠 Metastatic Cancer 🦠 Malignant Neoplasm of Lung 🦠 Malignant Neoplastic Disease
🗓️ Study Start (Actual) 1 August 2022
🗓️ Primary Completion (Estimated) 24 July 2024
✅ Study Completion (Estimated) 1 January 2025
👥 Enrollment (Estimated) 85
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE1
Locations:
📍 San Francisco, California, United States
📍 Aurora, Colorado, United States
📍 Jacksonville, Florida, United States
📍 Rochester, Minnesota, United States
📍 New York, New York, United States
📍 Chapel Hill, North Carolina, United States
📍 Fairfax, Virginia, United States
📍 Milwaukee, Wisconsin, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * Male or female subjects ≥ 18 years of age
    • * Histologic or cytologic evidence of NSCLC
    • * Known KRAS G12C mutation
    • * The subject must have received prior therapy with a KRAS G12C inhibitor and experienced progression
    • * Must have received appropriate treatment with at least one prior systemic regimen, but no more than 3 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:

    • * Prior chemotherapy, targeted therapies, radiotherapy, immunotherapy or treatment with an investigational agent within 14 days of receipt of study drug (within 6 weeks for nitrosoureas, mitomycin C and chest radiation; within 6 months prior to Cycle 1 Day 1 for chest radiation \> 30Gy)
    • * History of prior malignancy, with the exception of curatively treated malignancies
    • * Major surgery within 4 weeks (excluding placement of vascular access)
    • * Exposure to strong CYP3A4 inhibitors or inducers within 14 days prior to the first dose and during the course of therapy
    • * Exposure to strong inhibitors of breast cancer resistance protein (BCRP) within 14 days prior to the first dose and during the course of therapy
    • * Symptomatic brain metastases requiring steroids or other local interventions within the 2 weeks prior to initiation of therapy
    • * 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 1 year
    • * History of rhabdomyolysis or interstitial lung disease
    • * Concurrent ocular disorders
    • * Concurrent heart disease or severe obstructive pulmonary disease
    • * Subjects with the inability to swallow oral medications
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 2 May 2022
  • First Submitted that Met QC Criteria 10 May 2022
  • First Posted 17 May 2022

Study Record Updates

  • Last Update Submitted that Met QC Criteria 19 July 2023
  • Last Update Posted 21 July 2023
  • Last Verified July 2023