A Phase 1/1b Study to Evaluate the Safety and Tolerability of AB801 Monotherapy and Combination Therapy in Participants With Advanced Malignancies

• AB801 is an AXL 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 is the study drug is acting on your body

This is a dose escalation/expansion study. Dose Escalation means that the amount of the study drug given will be increased in each group of research participants, to find the most appropriate dose for further study.  In the dose expansion part of the study, a larger number of people receive the study drug dose determined to be appropriate in the dose escalation part of the study.

The study regimen will be given in cycles.  Each cycle is 21 days.

You will receive the study drug daily by mouth with room temperature water, on an empty stomach (no food or drink, other than water, for 2 hours before and 1 hour after taking the study drug). Study staff will instruct you if you need to fast from midnight prior to your clinic visit.  You will be provided with study drug to take at home on the days you do not have to visit the study site. You will be requested to complete a diary to document when you take the study drug each day.

In the dose expansion part of the study, a larger number of people receive the study drug dose determined to be appropriate in the dose escalation part of the study. In dose expansion, the study drug 1 will be combined with docetaxel with or without study drug 2.

You are being asked to participate in the dose expansion part of the study. In the dose expansion phase of the study there will be two groups, Group 1 and Group 2. You will be in Group 1 if you have a mutation of a gene called STK11 or deletion of the STK 11 gene. If you do not have a mutation or deletion or have not been tested for a mutation or deletion of STK11, then you will be in Group 2.

If you are in Group 1, you will receive study drug 1 with Docetaxel and study drug 2. If you are in Group 2, you will receive study drug 1 with Docetaxel.

The study regimen will be given in cycles.  Each cycle is 21 days. You will receive study drug 1 by mouth daily on the first day of each cycle. You will receive the study drug daily by mouth with room temperature water, on an empty stomach (no food or drink, other than water, for 2 hours before and 1 hour after taking study drug 1). Study staff will instruct you if you need to fast from midnight prior to your clinic visit.

If you are in Group 1, you will also receive study drug 2 as a 30-minute IV infusion followed by a 30-minute rest period. After the 30-minute rest period, you will receive docetaxel as a 60-minute infusion. If you are in Group 2, you will receive docetaxel administered on day 1 of each cycle as a 60-minute infusion.  You will be provided with study drug to self-administer at home on the days you do not have to visit the study site.