A Phase 1, open-label, dose-escalation and dose-expansion study evaluating AO-252, a protein-protein interaction inhibitor of TACC3, in advanced solid tumors including triple-negative breast cancer (TNBC), high-grade serous ovarian carcinoma (HGSOC), and endometrial cancer.

MC #24-13

NCT #
Condition(s)
Breast Cancer, Endometrial Cancer, Ovarian/ Peritoneal/ Fallopian Tube Cancer
Molecular Target(s)
TP53
Drug Classification(s)
Molecular Targeted Therapy
Agents(s)
AO-252
Phase(s)
I

Mechanism of Action

  • AO-252 is a protein-protein interaction inhibitor of TACC3

Purpose

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

  • How safe and tolerable is AO-252
  • What is the maximum tolerated dose of AO-252

Study Design

Part of this study involves helping choose the dose strength of the study drug to give to patients with TNBC, HGSOC, or endometrial cancer (this is called the indication). At the beginning of the study, 1 patient will be given a low dose strength of the study drug. The study doctor and staff will monitor the patient to see if the patient experiences any unwanted health effects. If the lowest dose strength does not cause unacceptable side effects, the dose strength will slowly be increased as new patients take part in the study. This is called dose escalation.  Dose escalation will continue until the best dose is found or until side effects cannot be tolerated.  If patients have unacceptable side effects when receiving a certain dose strength, the increasing of dose strengths for new patients will stop.  After a dose strength is chosen, that dose strength will be given to about 30 patients per indication. Additional patients may also be enrolled at lower doses to obtain additional information about the study drug.

Not all patients will stay in the study for the same amount of time.  Dosing with the study drug will be divided into “cycles” of 28 days each.  The number of cycles you receive will depend on how well you tolerate the study drug, and your overall condition.

Location

Mary Crowley Cancer Research - Medical City Dallas

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