A Phase 1/2 Study to Assess the Safety and Antitumor Activity of APL-5125 in Adults with Selected Advanced Solid Tumors

• APL-5125 is a CK2α inhibitor

In this study, the sponsor and investigators want to learn:

• How much of the study drug can be given with an acceptable level of side effects
• The effects of the study drug (good and bad)
• How much of the study drug is absorbed into the blood and how fast it is removed
• How the study drug is acting on your body
• If research tests can be used in the future to predict who will benefit from APL-5125

This clinical trial consists of 2 phases: Phase 1 and Phase 2. The Phase 1 dose escalation part aims to find the best doses of the study drug for treatment and to study the safety of the study drug. You will be assigned a certain dose following a predefined plan, based on when you are enrolled in the trial. You will not have a choice as to what dose you are assigned to.

During the Phase 1 dose escalation part of the trial there will be up to 5 dose levels. There will be up to 60 patients in Phase 1 that will be enrolled and treated. It is expected that between 3 and 12 patients will be dosed at each dose level.

Depending on when you enroll, you will be treated with one of the following doses of the study drug:

• Cohort 1: 30 mg daily
• Cohort 2: 60 mg daily
• Cohort 3: 100 mg daily
• Cohort 4: 150 mg daily
• Cohort 5: 200 mg daily

Your study doctor will inform you of the dose of the study drug you are to take and how often you are to take the study drug.

Depending on data from the Phase 1 dose escalation part of the study, the sponsor may start Phase 1 sub-study cohorts.  The sub-study cohorts may enroll up to 12 patients each. The purpose of these sub-study cohorts will be to evaluate how effective the study drug is in patients with different cancer types.

Two doses may be chosen for further evaluation in Phase 2.  Approximately 40 more patients may be enrolled in Phase 2. The purpose of Phase 2 is to see how effective the study drug is in treating patients with colorectal cancer with a certain genetic status.

All patients will be treated in 28-day treatment cycles until the cancer (disease) progresses/relapses, or there are unacceptable side effects, or you decide you no longer wish to continue in the study or your study doctor decides it is best for you to stop.