Study drug QTX3046 for KRAS G12D mutated advanced solid tumors

What is the Purpose of this Study?

We are doing this study to find out if an experimental drug called QTX3046 (the study drug) is a safe and effective option for KRAS G12D 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 G12D Mutation

Who Can Participate in the Study?

Adults ages 18+ who:

  • Have a locally advanced or metastatic form of cancer with a solid tumor
  • Have a documented KRAS G12D mutation in their tumor(s)
  • Have had their cancer progress after at least 1 line of standard therapy

For more information, contact the study team at gi-oncology-cru@dm.duke.edu or 919-668-1861.

Age Group
Adults

What is Involved?

If you choose to join this study, you will:

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

Study Details

Full Title
[QTX3046-101] A Phase 1 Trial Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of QTX3046 in Patients with Advanced Solid Tumors with KRASG12D Mutations
Principal Investigator
Professor of Medicine
Protocol Number
IRB: PRO00116299
NCT: NCT06428500
Phase
Phase I
ClinicalTrials.gov
Enrollment Status
OPEN TO ACCRUAL
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