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Purpose

This study will assess the safety and efficacy of VS-7375 alone and in combination with cetuximab or panitumumab and cetuximab plus mFOLFOX in patients with metastatic KRAS G12D - mutated Colorectal Cancer

Condition

Eligibility

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

Inclusion Criteria

  • Histopathology confirmed metastatic CRC - Measurable disease per RECIST 1.1 - Local testing confirmed KRAS G12D mutation (tissue required for confirmatory central testing) - ECOG PS=0 or 1 2L+ patients: - Must have received at least 1 standard chemotherapy for metastatic colorectal adenocarcinoma - Have documented disease progression during or following their most recent prior line of therapy - Have either stable disease, partial response (PR), or complete response (CR) by RECIST v1.1 as the best overall response (BOR) during at least 1 prior systemic therapy. 1L patients: - Treatment-naïve or received no more than 1 cycle of standard systemic therapy for metastatic disease.

Exclusion Criteria

  • Have any other documented co-existing common RAS mutation(s) - Prior anti-cancer Tx within 4 weeks or drug-specific timeline within first treatment dose, whichever shorter - Major surgery within 4 weeks of first treatment dose - Radiation therapy (RT) within 1 week of first treatment dose - Receipt of prior direct RAS inhibitor - Receipt of more than 1 investigational therapy - Untreated or symptomatic CNS metastasis - Receipt of strong CYP3A4 inhibitor/inducer or CYP3A4 sensitive substrates with narrow therapeutic index within 14 days or drug-specific timeline within first treatment dose, whichever is shorter - Receipt of PPI or H2 blocker within 5 days - Inability to swallow oral medication - Other protocol-defined inclusion/exclusion criteria may apply

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover Assignment
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
VS-7375 Monotherapy or Preferred Combination in 2L+ CRC 		Participants randomized to a treatment in 2:1 ratio
  • Drug: VS-7375
    Taken by mouth
  • Drug: cetuximab
    Intravenous infusion
  • Drug: panitumumab
    Intravenous infusion
Experimental
VS-7375 with chosen regimen in 2L+ CRC
  • Drug: VS-7375
    Taken by mouth
  • Drug: cetuximab
    Intravenous infusion
  • Drug: panitumumab
    Intravenous infusion
Experimental
VS-7375 + cetuximab and mFOLFOX in 1L CRC
  • Drug: Cetuximab + mFOLFOX6
    Intravenous infusion

Recruiting Locations

START Los Angeles
Los Angeles, California 90025
Contact:
START Hope Team
424-465-1820
hopeteam@startresearch.com

START Midwest
Grand Rapids, Michigan 49546
Contact:
START Hope Team
616-954-5554
hopeteam@startresearch.com

START New Jersey
East Brunswick, New Jersey 08816
Contact:
START Hope Team
732-426-4750
hopeteam@startresearch.com

START Dallas Fort Worth
Fort Worth, Texas 76104
Contact:
START Hope Team
682-350-3010
hopeteam@startresearch.com

START Mountain Region
West Valley City, Utah 84119
Contact:
START Hope Team
801-907-4750
hopeteam@startresearch.com

More Details

Status
Recruiting
Sponsor
Verastem, Inc.

Study Contact

Verastem Call Center
7812924204
VS-7375-203TrialSupport@verastem.com

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.