Study drug QTX3544 for participants with KRAS G12V solid tumors (QTX3544-201)

What is the Purpose of this Study?

We are doing this study to find out if an investigational drug called QTX3544 (the study drug) is a safe and effective option for KRAS G12V mutated cancer. We want to know how well it works on its own and in combination with a drug called cetuximab, and we are also trying to find the best dose of the study drug to use.

What is the Condition Being Studied?

Solid Tumors with KRAS G12V Mutation

Who Can Participate in the Study?

Adults ages 18+ who:

  • Have locally advanced or metastic cancer with solid tumor(s) harboring KRAS G12V mutations
  • Have a life expectancy of more than 3 months

For more information, contact the study team at dana.a.warren@duke.edu.

Age Group
Adults

What is Involved?

If you choose to join this study, you will:

  • Take the study drug by mouth once per day
  • Get a random assignment (like a coin flip) to either get intravenous (IV) infusions of cetuximab once every week or not
  • Have blood draws and give urine samples
  • Have regular CT or MRI scans

Study Details

Full Title
A Phase 1 Trial Evaluating the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-Tumor Activity of QTX3544 in Patients with Advanced Solid Tumors with KRASG12V Mutations
Principal Investigator
Headshot of John Strickler
Professor of Medicine
Protocol Number
IRB: PRO00117630
NCT: NCT06715124
Phase
Phase I
ClinicalTrials.gov
Enrollment Status
OPEN TO ACCRUAL