Purpose of this Study
We are doing this study to find out if an experimental drug called LY4066434 (the study drug) is a safe and effective option for patients who have solid tumor(s) with a KRAS mutation. We want to know how well the study drug works on its own and in combination with other anti-cancer therapies.
Who Can Participate?
Eligibility
Adults ages 18+ who:
- Have evidence of KRAS G12C, G12D, G12V, G12A, G12S, or G13D mutation in their tumor(s)
- Are not pregnant or breastfeeding
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 choose to join this study, you will get a random assignment (like a coin flip) to either take the study drug on its own or in combination with other, approved cancer therapies.
If you are assigned to take the study drug alone, you will take it by mouth twice each day. If you are assigned to get the study drug in combination with other drugs (cetuximab and/or chemotherapy), you will get another random assignment to take 1 of 6 possible drug combinations.
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
No
Study Details
Full Title
A Phase 1a/1b Study of the pan-KRAS Inhibitor LY4066434 in Participants with
KRAS Mutant Solid Tumors (J5Q-OX-JRDA)
KRAS Mutant Solid Tumors (J5Q-OX-JRDA)
Principal Investigator
John
Strickler
Protocol Number
PRO00117213
NCT ID
NCT06607185
Phase
I
Enrollment Status
Pending Open to Enrollment