Purpose

This study will assess the safety and efficacy of VS-6766 monotherapy or VS-6766 in combination with defactinib in subjects with recurrent Non-small cell lung cancer.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Male or female subjects ≥ 18 years of age - Histologic or cytologic evidence of NSCLC - Known KRAS mutation - The subject must have received appropriate prior therapy - 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 or KRAS - Exposure to strong CYP2C9 and CYP3A4 inhibitors or inducers within 7 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 - Active skin disorder that has required systemic therapy within the past 1 year - History of rhabdomyolysis - Concurrent ocular disorders - Concurrent heart disease or severe obstructive pulmonary disease - Subjects with the inability to swallow oral medications

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Part A
To determine the optimal regimen, either VS-6766 monotherapy or VS-6766 in combination with defactinib, for subsequent evaluation for efficacy in the expansion phase (Part B).
  • Drug: VS-6766
    Monotherapy
  • Drug: VS-6766 and Defactinib
    Combination therapy
    Other names:
    • VS-6766 and VS-6063
Experimental
Part B
To determine the efficacy of the optimal regimen identified from Part A
  • Drug: VS-6766
    Monotherapy
  • Drug: VS-6766 and Defactinib
    Combination therapy
    Other names:
    • VS-6766 and VS-6063

Recruiting Locations

Georgetown University Medical Center
Washington, District of Columbia 20007
Contact:
Joshua Reuss
Joshua.E.Reuss@gunet.georgetown.edu

More Details

Status
Recruiting
Sponsor
Verastem, Inc.

Study Contact

Gloria Patrick
781-469-1594
gpatrick@verastem.com

Detailed Description

This is a multicenter, non-randomized, open-label Phase 1b/2 study designed to evaluate safety and tolerability and efficacy of VS-6766 versus VS-6766 in combination with defactinib in subjects with KRAS-MT NSCLC following treatment with an appropriate platinum-based regimen and an approved immune checkpoint inhibitor (CPI).

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.