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

• Status: Not yet recruiting
• Trial end date: 2025-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will assess the safety and efficacy of VS-6766 in combination with sotorasib in patients with G12C Non-Small Cell Lung Cancer (NSCLC) in patients who have been exposed to prior G12C inhibitor and those who have not been exposed to prior G12C inhibitor.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Verastem, Inc.
• Collaborator: Amgen

Criteria

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