A Phase 2 Study of VS-7375 in Patients With KRAS G12D-Mutated Colorectal Cancer
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)
- Colorectal Cancer
At a glance
- Phase
- Phase 2
- Study type
- Interventional
- Sponsor
- Verastem, Inc.
- Enrolment target
- 150
- Started
- 28 July 2026
- Main results due
- June 2027
- Study sites
- 19
- Registry updated
- 29 September 2026
Can you take part?
- Aged 18 years and over.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
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
What this study is about
In the sponsor’s own words, from the registry.
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
Study sites(19)
START Los Angeles
Los Angeles, California, United States
Recruiting
Valkyrie Clinical Trials (contact for more locations)
Los Angeles, California, United States
Recruiting
Moffitt Cancer Center
Tampa, Florida, United States
Recruiting
Indiana University, Simon Comprehensive Cancer Center
Indianapolis, Indiana, United States
Recruiting
START Midwest
Grand Rapids, Michigan, United States
Recruiting
Washington University
St Louis, Missouri, United States
Recruiting
START New Jersey
East Brunswick, New Jersey, United States
Recruiting
Perlmutter Cancer Center at NYU Langone Health (contact for more locations)
New York, New York, United States
Recruiting
Sarah Cannon Research Institute Oncology Partners
Nashville, Tennessee, United States
Recruiting
START Dallas Fort Worth
Fort Worth, Texas, United States
Recruiting
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Recruiting
START Mountain Region
West Valley City, Utah, United States
Recruiting
UVA Comprehensive Cancer Center
Charlottesville, Virginia, United States
Recruiting
Virginia Cancer Specialists
Fairfax, Virginia, United States
Recruiting
Virginia Mason Medical Center
Seattle, Washington, United States
Recruiting
Macquarie University Hospital
Macquarie Park, New South Wales, Australia
Recruiting
Calvary Mater Newcastle
Waratah, New South Wales, Australia
Recruiting
Icon Cancer Centre South Brisbane
South Brisbane, Queensland, Australia
Recruiting
Icon Cancer Centre Adelaide
Kurralta Park, South Australia, Australia
Recruiting
Showing 19 of 19 sites. 19 of the 19 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT07659795. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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