Phase 1 Study of Oral AO-252, a TACC3 Inhibitor, in Adults With Advanced Solid Tumors With or Without Brain Metastases Evaluating Safety, Dosage, and Anti-Tumor Effects

What this Trial Is About

Researchers are evaluating AO-252, a protein-protein interaction inhibitor targeting TACC3, for its safety, tolerability, and effectiveness in patients with advanced solid tumors, including those with brain metastases. This Phase 1 study aims to find the best dose to use in future studies and will assess pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity. Participants will receive AO-252 as oral tablets or capsules daily. The study includes two parts a dose escalation phase to determine the maximum tolerated dose and recommended Phase 2 dose, followed by a dose expansion phase where participants are assigned to specific dose levels based on initial findings. During the study, participants will be monitored for safety over 12 months in the dose escalation phase and up to 30 months in dose expansion, with assessments of tumor response and drug behavior in the body. Evaluations include regular safety checks, measurement of tumor activity, and pharmacokinetic profiling. Participants will be followed closely throughout the treatment period to track outcomes and any side effects.

A First-In-Human, Phase 1 Study Evaluating Oral TACC3 PPI Inhibitor, AO-252, in Advanced Solid Tumors With or Without Brain Metastases