A Phase 2, Open-label Study of VS-7375, an Oral KRAS G12D (ON/OFF) Inhibitor, With and Without an Anti-EGFR Antibody, and With an Anti-EGFR Antibody and Chemotherapy, in Patients With Metastatic KRAS G12D-Mutated Colorectal Adenocarcinoma (TARGET-D 203)
Status: Recruiting
Location: See all (14) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
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
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
United States
California
START Los Angeles
RECRUITING
Los Angeles
Valkyrie Clinical Trials (contact for more locations)
RECRUITING
Los Angeles
Florida
Moffitt Cancer Center
RECRUITING
Tampa
Indiana
Indiana University, Simon Comprehensive Cancer Center
RECRUITING
Indianapolis
Michigan
START Midwest
RECRUITING
Grand Rapids
New Jersey
START New Jersey
RECRUITING
East Brunswick
Tennessee
Sarah Cannon Research Institute Oncology Partners
RECRUITING
Nashville
Texas
START Dallas Fort Worth
RECRUITING
Fort Worth
The University of Texas MD Anderson Cancer Center
RECRUITING
Houston
Utah
START Mountain Region
RECRUITING
West Valley City
Virginia
UVA Comprehensive Cancer Center
RECRUITING
Charlottesville
Washington
Virginia Mason Medical Center
RECRUITING
Seattle
Other Locations
Australia
Icon Cancer Centre Adelaide
RECRUITING
Kurralta Park
Icon Cancer Centre South Brisbane
RECRUITING
South Brisbane
Contact Information
Primary
Verastem Call Center
VS-7375-203TrialSupport@verastem.com
7812924204
Backup
Luke Chung, MD
VS-7375-203Medical@verastem.com
Time Frame
Start Date:2026-07-28
Estimated Completion Date:2028-12
Participants
Target number of participants:150
Treatments
Experimental: VS-7375 Monotherapy or Preferred Combination in 2L+ CRC
Participants randomized to a treatment in 2:1 ratio
Experimental: VS-7375 with chosen regimen in 2L+ CRC
Experimental: VS-7375 + cetuximab and mFOLFOX in 1L CRC