A Phase I, First in Human, Dose-Escalation Study of UCT-03-008 in Participants with Advanced Solid Tumors

MC #22-13

NCT #
Condition(s)
Solid Tumor
Molecular Target(s)
CDK4/6
Drug Classification(s)
Molecular Targeted Therapy, Small Molecule
Agents(s)
UCT-03-008
Phase(s)
I

Mechanism of Action

UCT-03-008, CDK4/6 inhibitor, inhibits protein kinase from working and therefore, potentially stopping cancer cells to grow. Protein kinases are enzymes that are involved in the signaling pathway of cells that tell some cells to grow or to stop growing in the body.

Purpose

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

Study Design

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 treatment will be given in cycles. Each cycle is 28 days. You will take the study drug every day, by mouth, at the same time each day.

Location

Mary Crowley Cancer Research - Medical City Dallas

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