A phase 1/1b/2 study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of AMG 193 alone and in combination with docetaxel in subjects with advanced MTAP-null solid tumors

• AMG 193 is a PRMT5 inhibitor

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

• Whether study drug alone and in combination with docetaxel are safe and is an effective treatment option

Part 1 and Part 2:  The purpose of Part 1 and Part 2 is to look at what doses of AMG 193 alone or in combination with docetaxel are safe to take for people with metastatic or locally advanced solid tumors lacking MTAP. The study also evaluates the anti-cancer activity of AMG 193 alone or in combination with docetaxel in people with solid tumors lacking MTAP.

Part 1 consists of Parts 1a to 1k where AMG 193 is given alone. Part 1a looks at what doses and what dosing regimens of AMG 193 are safe for people to take. Parts 1c to 1h will confirm the safe dose identified in part 1a in different cancer types and determine the activity of  AMG 193 against the different types of cancer. Part 1j will compare 2 different formulations of AMG 193 tablets.  Part 1k will test if eating food changes the amount of AMG 193 in your blood.

The group you are assigned to may depend on when you join the study what type of cancer you have and if your tumor has loss of MTAP, or CDKN2A. Your study doctor or a member of the study staff will inform you which group of the study you will be enrolled into.