Phase 1/2 Study of Avutometinib (VS-6766) + Sotorasib in G12C NSCLC Patients (RAMP203)

This is an interventional treatment trial for Non Small Cell Lung Cancer focused on measuring NSCLC, KRAS G12C Read More

Inclusion Criteria:

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

• 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 (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