A Phase 2 Study of VS-7375 in Patients With KRAS G12D-Mutated Pancreatic Cancer
Recruiting · NCT07644559 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
29 locations listed across 16 US states.
- START- Los Angeles - Los Angeles, California, United States
- Cedars-Sinai Medical Center - Los Angeles, California, United States
- Valkyrie Clinical Trials - Los Angeles, California, United States
- Mayo Clinical Florida - Jacksonville, Florida, United States
- Moffitt Cancer Center - Tampa, Florida, United States
- Johns Hopkins University - Baltimore, Maryland, United States
- Massachusetts General Hospital - Boston, Massachusetts, United States
- Dana-Farber Cancer Institute - Boston, Massachusetts, United States
- University of Michigan - Ann Arbor, Michigan, United States
- START Midwest - Grand Rapids, Michigan, United States
- Mayo Clinical Rochester - Rochester, Minnesota, United States
- Washington University - St Louis, Missouri, United States
- START New Jersey - East Brunswick, New Jersey, United States
- NYU-Manhattan - New York, New York, United States
- University of North Carolina - Chapel Hill, North Carolina, United States
- Sarah Cannon Research Institute - Nashville, Tennessee, United States
- START Dallas - Fort Worth, Texas, United States
- MD Anderson Cancer Center - Houston, Texas, United States
- START- San Antonio - San Antonio, Texas, United States
- START- Mountain Region - West Valley City, Utah, United States
- UVA Health - Charlottesville, Virginia, United States
- Virginia Cancer Specialists - Fairfax, Virginia, United States
- Virginia Mason - Seattle, Washington, United States
- UW Health - Madison, Wisconsin, United States
- ICON Cancer Centre - South Brisbane, Australia
- Macquarie University Hospital - Sydney, New South Wales, Australia
- Sunnybrook Health Sciences Centre - Toronto, Ontario, Canada
- Princess Margaret Cancer Center - Toronto, Ontario, Canada
- ICON Kurralta Park - Kurralta Park, South Australia, Australia