A Phase 1/2 Study of ASP1570 in Participants with Locally Advanced or Metastatic Solid Tumors

• ASP1570 is a small molecule immuno-oncology agent that is expected to act through the activation of immune cells in the tumor microenvironment.

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

• How much of the study drug can be given alone and in combination with Pembro with an acceptable level of side effects
• The effects of the study drug alone and in combination with Pembro (good and bad)
• How much of the study drug alone and in combination with Pembro is absorbed into the blood and how fast it is removed
• If the study drug alone and in combination with Pembro prevents or slows tumor growth or shrinks existing tumors

This is a dose escalation/expansion study.

Dose Escalation

Part 1, the dose escalation phase of the study, will enroll small groups of participants to receive different doses of the study drug, starting with a small dose and increasing to a larger dose, to find the most appropriate dose for further study. At least 3 participants will be receiving the same dose before additional participants are enrolled to the next higher dose.

Dose Expansion

In Part 2, the dose expansion phase of the study, a larger number of participants with a specific tumor type (non-small cell lung cancer, melanoma, and a tumor type that showed a positive response to the study drug in dose escalation) will receive the study drug dose determined to be appropriate in the dose escalation part of the study. The dose of the study drug you may receive and the part, either receiving the study drug alone or in combination with Pembrolizumab, will be determined by when you enter into the study.

The Dose Expansion Phase may also include an option to participate in one of four smaller study groups, called an “Exploratory” cohort. The study groups are described below:

Food Effect

To learn about the effect of food on the study drug, up to 10 participants taking the study drug alone will be enrolled in a study regimen cycle with specific diet instructions. Participants enrolled in this cohort will be asked to start a meal 30 minutes before taking the study drug. The study drug should be taken immediately after finishing the meal, within no more than 10 minutes. The type of meal will need to be recorded by the participant. On Day 1 of Cycle 1 and Day 1 of Cycle 2, a standard meal should be eaten.

Prophylactic Steroid

This part of the study is aimed at assessing the safety and tolerability of the study drug when taken with corticosteroids. Up to 10 participants taking the study drug alone will be enrolled to this cohort. Corticosteroids will be taken for one week before the first dose of the study drug.

Intermittent Dosing

The intermittent dosing cohort will enroll up to 10 participants to assess the safety and tolerability of the study drug when administered in a periodical schedule.

Stepwise Dosing

This cohort will enroll up to 10 participants to assess the safety and tolerability of the study drug during a gradual increase in the dosage of the study drug. Participants will be given a determined dose of the study drug, which will be gradually increased for a total of one to two weeks. After this period, the study drug will then be given at targeted doses, which will increase periodically, and will be determined by your study doctor.