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.
Who Can Participate?
Eligibility
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
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 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
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
No
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
John
Strickler
Protocol Number
PRO00117630
NCT ID
NCT06715124
Phase
I
Enrollment Status
Open to Enrollment