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.
Who Can Participate?
Eligibility
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
Age Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
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
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
No
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
John
Strickler
Protocol Number
PRO00116299
NCT ID
NCT06428500
Phase
I
Enrollment Status
Open to Enrollment