NCT06136884

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

A Phase 1, Open-Label, Dose-escalation and Dose-Expansion Study Evaluating AO-252, a Protein-Protein Interaction Inhibitor of TACC3, in Patients With Advanced Solid Tumors With or Without Brain Metastases

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 86 (estimated)
• Sponsor: A2A Pharmaceuticals Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the safety, tolerability and efficacy of the study drug AO-252 and identify the best dose for use in future studies.

Detailed description

The purpose of this study is to characterize the safety, tolerability including determination of maximum tolerated dose (MTD), and identify the recommended Phase 2 dose (RP2D). The study will also look at pharmacokinetics (PK), pharmacodynamics (PD) and preliminary anti-tumor activity of AO-252 as a monotherapy in participants with advanced solid tumors with or without brain mestastases.

Conditions

• Solid Tumor Malignancies
• Brain Metastases From Solid Tumors

Interventions

Type	Name	Description
DRUG	AO-252	AO-252 will be administered oral tablets or capsules daily

Timeline

• Start date: 2023-11-02
• Primary completion: 2027-01-28
• Completion: 2028-01-27
• First posted: 2023-11-18
• Last updated: 2025-10-01

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study