Status:
ACTIVE_NOT_RECRUITING
Study of Avutometinib (VS-6766) + Adagrasib in KRAS G12C NSCLC Patients
Lead Sponsor:
Verastem, Inc.
Collaborating Sponsors:
Mirati Therapeutics Inc.
Conditions:
Non Small Cell Lung Cancer
KRAS Activating Mutation
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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 inhi...
Detailed Description
This is a multicenter, non-randomized, open-label Phase 1/2 study designed to evaluate safety, tolerability and efficacy of avutometinib (VS-6766) in combination with adagrasib in patients with KRAS G...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
85 Patients enrolled
Trial Details
Trial ID
NCT05375994
Start Date
August 1 2022
End Date
January 1 2026
Last Update
May 18 2025
Active Locations (8)
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1
UCSF Thoracic Oncology
San Francisco, California, United States, 94158
2
University of Colorado Hospital Anschutz Cancer Pavllion
Aurora, Colorado, United States, 80045
3
Mayo Clinic Cancer Center
Jacksonville, Florida, United States, 32224
4
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905