A Phase 2 Study of VS-7375 in Patients With KRAS G12D-Mutated Colorectal Cancer

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

  • Colorectal Cancer

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