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Recruiting

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

NCT07644559 · Verastem, Inc.
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Official title
A Phase 2, Open-label Study of VS-7375, an Oral KRAS G12D (ON/OFF) Inhibitor, as Monotherapy and With Cetuximab, in Patients With Metastatic KRAS G12D-Mutated Pancreatic Cancer (TARGET-D 201)
About this study
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
Eligibility criteria
Inclusion Criteria: * 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 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; 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
Study design
Enrollment target: 180 participants
Allocation: randomized
Masking: single
Age groups: adult, older_adult
Timeline
Starts: 2026-06-16
Estimated completion: 2028-12
Last updated: 2026-07-17
Interventions
Drug: VS-7375Drug: cetuximab
Primary outcomes
  • Confirmed ORR by blinded independent central review (BICR) per RESIST v1.1 (6 months)
  • To characterize the safety and tolerability of VS-7375 monotherapy or in combination with cetuximab, administered on a daily oral schedule in participants with KRAS G12D-mutated PDAC. (6 months)
Sponsor
Verastem, Inc. · industry
Contacts & investigators
ContactVerastem Call Center · contact · VS-7375-201TrialSupport@verastem.com · 7812924204
ContactLuke Chung, MD · contact · VS-7375-201Medical@verastem.com
All locations (18)
START- Los AngelesRecruiting
Los Angeles, California, United States
Valkyrie Clinical TrialsRecruiting
Los Angeles, California, United States
Moffitt Cancer CenterRecruiting
Tampa, Florida, United States
Johns Hopkins UniversityRecruiting
Baltimore, Maryland, United States
START MidwestRecruiting
Grand Rapids, Michigan, United States
Washington UniversityRecruiting
St Louis, Missouri, United States
START New JerseyRecruiting
East Brunswick, New Jersey, United States
University of North CarolinaRecruiting
Chapel Hill, North Carolina, United States
Sarah Cannon Research InstituteRecruiting
Nashville, Tennessee, United States
START DallasRecruiting
Fort Worth, Texas, United States
MD Anderson Cancer CenterRecruiting
Houston, Texas, United States
START- San AntonioRecruiting
San Antonio, Texas, United States
START- Mountain RegionRecruiting
West Valley City, Utah, United States
UVA HealthRecruiting
Charlottesville, Virginia, United States
Virginia Cancer SpecialistsRecruiting
Fairfax, Virginia, United States
UW HealthRecruiting
Madison, Wisconsin, United States
ICON Kurralta ParkRecruiting
Kurralta Park, South Australia, Australia
ICON Cancer CentreRecruiting
South Brisbane, Australia
A Phase 2 Study of VS-7375 in Patients With KRAS G12D-Mutated Pancreatic Cancer · TrialPath