PIKture-01: First-in-Human Study of the PI3KαH1047R Mutant-Selective Inhibitor OKI-219 as Monotherapy in Participants With Advanced Solid Tumors and as Part of Combination Therapy in Participants With Advanced Breast Cancer
This study is testing a new experimental drug called OKI-219, which is designed to block a specific genetic mutation that helps certain cancers grow. Researchers want to see if this drug is safe and effective when used alone or combined with other existing cancer treatments.
This trial is for adults with advanced solid tumors or breast cancer who have a specific genetic change known as a PI3K mutation. Participants must be generally healthy enough to carry out daily activities and have properly functioning kidneys, liver, and bone marrow.
Participants will receive the study drug and may also receive other approved cancer medications depending on the study group they are assigned to. You will remain on the treatment as long as it is working safely for you and your disease does not worsen.
The study is currently active but is no longer recruiting new participants. It is taking place at clinical research centers in Encinitas, La Jolla, and Los Angeles, California.
- 1The study focuses on targeting a specific gene mutation to stop cancer cells from growing.
- 2Researchers are testing the drug alone and in combinations with other standard therapies.
- 3Participation requires a confirmed PI3K mutation in your tumor or blood sample.
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