Study of Avutometinib (VS-6766) + Adagrasib in KRAS G12C NSCLC Patients (RAMP204)

V

Verastem

Status and phase

Enrolling
Phase 2
Phase 1

Conditions

Metastatic Cancer
Advanced Cancer
Malignant Neoplastic Disease
KRAS Activating Mutation
Malignant Neoplasm of Lung
Non Small Cell Lung Cancer

Treatments

Drug: avutometinib (VS-6766) and adagrasib

Study type

Interventional

Funder types

Industry

Identifiers

NCT05375994
VS-6766-204

Details and patient eligibility

About

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.

Full description

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.

Enrollment

85 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

85 participants in 2 patient groups

avutometinib(VS-6766)+adagrasib
Experimental group
Description:
To determine the recommended phase 2 dose (RP2D) for VS-6766 in combination with adagrasib in G12C inhibitor exposed patients
Treatment:
Drug: avutometinib (VS-6766) and adagrasib
avutometinib (VS-6766)+adagrasib RP2D
Experimental group
Description:
To determine the efficacy of the RP2D identified from Part A in G12C inhibitor exposed patients
Treatment:
Drug: avutometinib (VS-6766) and adagrasib

Trial contacts and locations

8

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Central trial contact

Verastem Call Center

Data sourced from clinicaltrials.gov

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