A Phase 1, Multicenter, Open-Label, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of Intravenously Administered KT-253 in Adult Patients with High Grade Myeloid Malignancies and Acute Lymphocytic Leukemia, Lymphoma and Advanced Solid Tumors

• KT-253 is an MDM2 degrader

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 KT-253
• How the study drug is acting on your body

This is a dose escalation 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. Once the maximum tolerated dose is found, up to 20 additional patients with solid tumors may be enrolled at the maximum dose level.

The dose of the study drug you receive will depend on when you enroll in the study.

The study regimen will be given in cycles.  Each cycle is 21 days.  You will receive the study drug on Day 1 every 21 days. You will receive the study drug as a slow injection into a vein in your arm (infusion). The infusion will be given over approximately 60 minutes. During the study, the dose of the study drug may be changed (reduced or increased) depending on your body’s response to the study drug and data obtained from the study