Study of VS-6766 + Adagrasib in KRAS G12C NSCLC Patients

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

Summary

This study will assess the safety and efficacy of VS-6766 in combination with agagrasib in patients with G12C Non-Small Cell Lung Cancer (NSCLC) who have been exposed to prior G12C inhibitor and experienced progressive disease.

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

Details

• Lead Sponsor: Verastem, Inc.
• Collaborator: Mirati Therapeutics Inc.
• Treatments: Adagrasib

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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