Purpose of this Study
We are doing this study to see if the study drug, QTX3034, either with or without cetuximab, is safe and effective for treating KRAS G12D mutated cancer. We are also trying to find the best dose of QTX3034 to use.
Who Can Participate?
Eligibility
Adults with solid tumors that:<ul>
<li>Are locally advanced or metastatic</li>
<li>Contain a KRAS G12D mutation</li>
<li>Have worsened following at least 1 line of standard therapy</li></ul>
For more information about this study, please contact the study team at 919-668-1861.
<li>Are locally advanced or metastatic</li>
<li>Contain a KRAS G12D mutation</li>
<li>Have worsened following at least 1 line of standard therapy</li></ul>
For more information about this study, please contact the study team at 919-668-1861.
What is Involved?
If you choose to join this study, you will:<ul>
<li>Take the study drug, QTX3034, by mouth twice every day</li>
<li>Depending on which group you are assigned to, you may also get IV infusions of cetuximab once every week</li>
<li>Have your tumor biopsied</li>
<li>Give blood and urine samples</li>
<li>Have regular CT or MRI scans</li></ul>
<li>Take the study drug, QTX3034, by mouth twice every day</li>
<li>Depending on which group you are assigned to, you may also get IV infusions of cetuximab once every week</li>
<li>Have your tumor biopsied</li>
<li>Give blood and urine samples</li>
<li>Have regular CT or MRI scans</li></ul>
Study Details
Full Title
[QTX3034-001] A Phase 1 Trial evaluating the Safety, Tolerability, PK, and Efficacy of QTX3034 in Patients with Solid Tumors with KRASG12D mutation
Principal Investigator
John
Strickler
Protocol Number
PRO00114908
NCT ID
NCT06227377
Phase
I
Enrollment Status
Open to Enrollment