VS-7375 in Advanced KRAS G12D-Mutant Solid Tumors

What is the Purpose of this Study?

This study focuses on people who have been diagnosed with a solid tumor that contains a specific change (mutation) in the KRAS gene. One common mutation in KRAS is called G12D; participants in this study will have the G12D mutation. Slots may be available in groups of patients with pancreatic adenocarcinoma, non-small cell lung cancer, colorectal cancer, and any other solid tumor with a KRAS G12D mutation. The purpose of the study is to determine the safety and best dose of an experimental drug called VS-7375 in these patients.VS-7375 is a drug that was specifically developed to target the G12D mutation in KRAS. The goal is to block the effects of this mutation, slowing down or stopping the growth of cancer cells without affecting normal cells. Study procedures include physical exams, blood and urine sample lab collection, electrocardiogram, imaging scans, biopsy, and drug administration. Researchers also aim to determine whether VS-7375 will provide a treatment benefit, as well as whether the drug can safely be combined with other treatments that are already approved by the U.S. Food and Drug Administration (FDA) to treat certain types of cancers.


Eligibility

  • * Individuals ≥18 years of age.
  • * Agreement to sign and date an informed consent form (ICF) approved by the Institutional Review Board (IRB)/Independent Ethics Committee (IEC).
  • * Histologic or cytologic evidence of locally advanced unresectable or metastatic solid tumor harboring a KRAS G12D mutation.
  • * Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
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Where can I participate?

  • CS Cancer at Cedars-Sinai Medical Center : Shannon Cyhan
  • CS Cancer at The Angeles Clinic and Research Institute : Shannon Cyhan


More about this Clinical Trial

What is the full name of this clinical trial?

VS-7375-101: A Phase 1/2a, Open-label Study of VS-7375, a KRAS G12D Inhibitor, as Monotherapy and in Combination, in Patients with Advanced KRAS G12D-Mutant Solid Tumors

Study Details
Disease Type/Condition

Unknown Sites

Principal Investigator

Osipov, Arsen

Co-Investigators

Andrew Hendifar, Cathie T Chung, Erwin Grussie, Inderjit Mehmi, Jun Gong, Justin Moyers, Kamya Sankar, Karen Reckamp, Kristopher Wentzel, Omid Hamid

Age Group

Adult

Phase

I/II

IRB Number

STUDY00004494

ClinicalTrials.gov ID

NCT07020221

Key Eligibility
ClinicalTrials.gov

How do I learn more about this study?
Name

Shannon Cyhan

Email
Shannon.Cyhan@cshs.org
Study Detail
Disease Type/Condition

Unknown Sites

Principal Investigator

Osipov, Arsen

Age Group

Adult

Phase

I/II

IRB Number

VS-7375-101

ClinicalTrials.gov ID

NCT07020221

Key Eligibility
ClinicalTrials.gov

Contact
Name

Shannon Cyhan

Email
Shannon.Cyhan@cshs.org