Phase 1/2 Study of VS-6766 + Sotorasib in G12C NSCLC Patients

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