A Phase 1/2a, Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Evidence of Antitumor Activity of JAB-2485 in Adult Patients With Advanced Solid Tumors

• JAB-2485 is a small molecule Aurora A inhibitor.  Inhibition of Aurora A activity at the cellular level induces apoptosis and inhibits tumor growth.

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

The study will be conducted in two phases: dose escalation (phase 1) and dose expansion (phase 2a).

During the dose escalation phase (phase 1), the daily dose of JAB-2485 you receive will depend on which dose level is open when you enter the study. The first few people to take part in this study will take a lower dose of JAB-2485. Then, if it is safe, people who join the study later will take a higher dose. During this time, your dose level will not be escalated. The dose expansion phase (phase 2a) will be initiated once the recommended dose for phase 2 (RP2D) is determined to be the best tolerated dose by phase 1 dose exploration. During phase 2a, the dose of JAB-2485 will never be higher than it was when you started the study.

If you decide to participate in this study, you will be asked to visit the study site approximately 4 times over Cycle 1, either about 4 times (if enrolled in the dose escalation phase) or about one time (if enrolled in the dose expansion phase) during Cycle 2, and about once in Cycle 3 and the subsequent cycles unless there is additional testing requested by study.