VS-7375 as Monotherapy and With Cetuximab in Metastatic KRAS G12D-Mutated Pancreatic Cancer

Purpose of Study

What is the Purpose of this Study?

This study focuses on people who have been diagnosed with metastatic pancreatic ductal adenocarcinoma with a specific change (mutation) in the KRAS gene. The purpose of the study is to determine the safety and effectiveness of an experimental drug called VS-7375 in treating metastatic KRAS G12D-mutated pancreatic cancer when given alone or in combination with the standard treatment, cetuximab. KRAS is a gene that can develop specific changes, which can lead to uncontrolled cell growth and cancer. One common mutation in KRAS is called G12D; to participate in this study, the change in the KRAS gene must be G12D. VS-7375 is a drug that is specifically developed to target the G12D mutation in KRAS. Cetuximab is a targeted therapy that is approved by the U.S. Food and Drug Administration (FDA). Researchers aim to determine the best dose of VS-7375, any side effects, and how many patients benefit while taking the drug. Another goal of the study is to evaluate whether VS-7375 will provide a treatment benefit to patients with metastatic pancreatic ductal adenocarcinoma that have a KRAS G12D mutation. Study procedures include blood and urine sample lab collection, electrocardiograms, echocardiograms, imaging scans, biopsies, and drug administration.


Study Eligibility

Eligibility


  • * 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
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Study Sites

Where can I participate?



  • CS Cancer at Beverly Hills : Sandy Gutierrez
  • CS Cancer at Cedars-Sinai Medical Center : Sandy Gutierrez


More about this Clinical Trial

What is the full name of this clinical trial?

VS-7375-201: A Phase 2, Open-label Study of VS-7375, an Oral KRAS G12D Inhibitor, as Monotherapy and with Cetuximab, in Patients with Metastatic KRAS G12D-Mutated Pancreatic Cancer

Study Details
Disease Type/Condition

Pancreas

Principal Investigator
1

Osipov, Arsen

Co-Investigators

Andrew Hendifar, David Hoffman, Emily Kaymen, Jeremy Lorber, Jun Gong, Kevin Scher

Age Group

Adult

Phase

II

IRB Number

STUDY00005129

ClinicalTrials.gov ID

NCT07644559

Key Eligibility
ClinicalTrials.gov

How do I learn more about this study?

Name

Sandy Gutierrez

Email

Sandy.Gutierrez@cshs.org
Study Detail
Disease Type/Condition

Pancreas

Principal Investigator

Osipov, Arsen

Age Group

Adult

Phase

II

IRB Number

VS-7375-201

ClinicalTrials.gov ID

NCT07644559

Key Eligibility
ClinicalTrials.gov

Contact
Name

Sandy Gutierrez

Email
Sandy.Gutierrez@cshs.org