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

Recruiting now · Phase 2

Conditions studied: Colorectal Cancer

In brief

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

Key facts

Study ID

NCT07659795

Run by

Verastem, Inc.

People needed

150

Starts

2026-07-28

Expected to finish

2028-12-01

Last updated by the study team

2026-08-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• START Los Angeles — Los Angeles, California, United States (enrolling)
• Valkyrie Clinical Trials — Los Angeles, California, United States (enrolling)
• Moffitt Cancer Center — Tampa, Florida, United States (enrolling)
• START Midwest — Grand Rapids, Michigan, United States (enrolling)
• START New Jersey — East Brunswick, New Jersey, United States (enrolling)
• START Dallas Fort Worth — Fort Worth, Texas, United States (enrolling)
• START Mountain Region — West Valley City, Utah, United States (enrolling)
• UVA Comprehensive Cancer Center — Charlottesville, Virginia, United States (enrolling)
• Icon Cancer Centre South Brisbane — South Brisbane, Queensland, Australia (enrolling)
• Icon Cancer Centre Adelaide — Kurralta Park, South Australia, Australia (enrolling)

Full record on ClinicalTrials.gov

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