An Early Phase Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of PEEL-224 in Patients with Advanced Solid Tumors

PEEL-224 is a small molecule topoisomerase 1 (TOP1) inhibitor, which may lead to inhibiting the repair of single-strand DNA breaks, DNA replication, and tumor cell growth in susceptible tumor cell populations.

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
• If research tests can be used in the future to predict who will benefit from PEEL-224

This is a dose escalation/expansion study.

In the Dose Escalation phase, 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. The main goal is to find the highest safe dose of PEEL-224. In the Dose Escalation phase, different doses of PEEL-224 are tested to see how much PEEL-224 participants can safely receive without feeling too sick.

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.

You may take part in Dose Escalation or Dose Expansion, but not both. Your study doctor will tell you which part of the study you will take part in and what dose you will receive.

In both parts of the study, we will also find out how much of the study drug is in your blood and how long it stays in your blood. This is known as “pharmacokinetics”, or PK for short.