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

Recruiting now · Phase 2

Conditions studied: Pancreatic Ductal Adenocarcinoma (PDAC), G12D Mutated KRAS

In brief

This study will assess the safety and efficacy of VS-7375 alone and in combination with cetuximab in patients with metastatic KRAS G12D - mutated Pancreatic Cancer

Key facts

Study ID

NCT07644559

Run by

Verastem, Inc.

People needed

180

Starts

2026-06-16

Expected to finish

2028-12-01

Last updated by the study team

2026-08-07

Who can join

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

You may qualify if…

• Histopathology confirmed PDAC
• Measurable disease per RECIST 1.1
• Local testing confirmed KRAS G12D mutation (tissue required for confirmatory central testing)
• ECOG PS=0 or 1
• Adequate organ function
• VS-7375 + cetuximab (2L PDAC) :
• Received only 1 prior Tx in the metastatic setting; prior adjuvant counts as a line if progressed within 6 months
• VS-7375 + cetuximab (1L PDAC) :
• Treatment-naïve or received ≤ 1 cycle of SoC 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; RT to brain or lung within 2 weeks of first treatment dose
• History of drug-induced Interstitial Lung Disease
• Receipt of prior direct RAS inhibitor
• 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)
• Cedars-Sinai Medical Center — Los Angeles, California, United States (enrolling)
• Valkyrie Clinical Trials — Los Angeles, California, United States (enrolling)
• Moffitt Cancer Center — Tampa, Florida, United States (enrolling)
• Johns Hopkins University — Baltimore, Maryland, United States (enrolling)
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States (enrolling)
• University of Michigan — Ann Arbor, Michigan, United States (enrolling)
• START Midwest — Grand Rapids, Michigan, United States (enrolling)
• Washington University — St Louis, Missouri, United States (enrolling)
• START New Jersey — East Brunswick, New Jersey, United States (enrolling)
• NYU-Manhattan — New York, New York, United States (enrolling)
• University of North Carolina — Chapel Hill, North Carolina, United States (enrolling)
• Sarah Cannon Research Institute — Nashville, Tennessee, United States (enrolling)
• START Dallas — Fort Worth, Texas, United States (enrolling)
• MD Anderson Cancer Center — Houston, Texas, United States (enrolling)
• START- San Antonio — San Antonio, Texas, United States (enrolling)
• START- Mountain Region — West Valley City, Utah, United States (enrolling)
• UVA Health — Charlottesville, Virginia, United States (enrolling)
• Virginia Cancer Specialists — Fairfax, Virginia, United States (enrolling)
• Virginia Mason — Seattle, Washington, United States (enrolling)
• UW Health — Madison, Wisconsin, United States (enrolling)
• ICON Kurralta Park — Kurralta Park, South Australia, Australia (enrolling)
• ICON Cancer Centre — South Brisbane, Australia (enrolling)

Full record on ClinicalTrials.gov

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