Pan-KRAS Inhibitor LY4066434 +/- SOC drugs in KRAS Mutant Solid Tumors (J5Q-OX-JRDA) - Clinical Trial

What is the 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.

What is the Condition Being Studied?

Tumors That Have a KRAS G12C, G12D, G12V, G12A, G12S, or G13D Mutation

Who Can Participate in the Study?

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

For more information, contact the study team at dana.a.warren@duke.edu.

Age Group
Adults

What is Involved?

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.

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)
Principal Investigator
Medical Oncologist
Protocol Number
IRB: PRO00117213
NCT: NCT06607185
Phase
Phase I
ClinicalTrials.gov
Enrollment Status
Open for Enrollment