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Keep this study
Lead
Verastem, Inc.
With
Mirati Therapeutics Inc.
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 G12C mutant NSCLC who have been exposed to prior G12C inhibitor and experienced progressive disease.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | Study of Avutometinib (VS-6766) + Adagrasib in KRAS G12C NSCLC Patients
