Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Collin Blakely, MD
Headshot of Collin Blakely
Collin Blakely

Description

Summary

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

Official Title

A Phase 1/2 Study of VS-6766 in Combination With Adagrasib in Patients With KRAS G12C Mutant Non-Small Cell Lung Cancer (NSCLC) (RAMP 204)

Details

This is a multicenter, non-randomized, open-label Phase 1/2 study designed to evaluate safety, tolerability and efficacy of Avutometinib (VS-6766) in combination with adagrasib in patients with KRAS G12C mutant NSCLC who have been exposed to prior G12C inhibitor and experienced progressive disease.

Keywords

Non Small Cell Lung Cancer, KRAS Activating Mutation, Advanced Cancer, Metastatic Cancer, Malignant Neoplasm of Lung, Malignant Neoplastic Disease, NSCLC, KRAS G12C, Adagrasib, Avutometinib(VS-6766), Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Neoplasm Metastasis, Neoplasms, Avutometinib (VS-6766) and adagrasib, Avutometinib(VS-6766)+adagrasib, Avutometinib (VS-6766)+adagrasib RP2D

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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

Locations

  • UCSF Thoracic Oncology accepting new patients
    San Francisco California 94158 United States
  • University of Colorado Hospital Anschutz Cancer Pavllion accepting new patients
    Aurora Colorado 80045 United States

Lead Scientist at UCSF

  • Collin Blakely, MD
    Dr. Blakely is a medical oncologist specializing in the treatment of lung cancer. He received his Bachelor of Science degree in Molecular and Cellular Biology from the University of Washington and attended the Perelman School of Medicine at the University of Pennsylvania in the Medical Scientist Training Program.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Verastem, Inc.
ID
NCT05375994
Phase
Phase 1/2 research study
Study Type
Interventional
Participants
Expecting 85 study participants
Last Updated