Phase 1 Study of AO-252 for Advanced Solid Tumors
This study is testing a new oral drug called AO-252 in adults with advanced solid tumors, including those with brain metastases. AO-252 is a targeted therapy that works by blocking TACC3 PPI. To join, you must have a solid tumor with a specific genetic change (TP53 mutation/loss) and have already received at least one other treatment. The main goals are to find out how safe AO-252 is, what side effects it might cause, and to determine the best dose for future studies. Researchers will also look for early signs of whether the drug is effective against cancer. This study plans to enroll 86 participants, but its current status is unclear.
- Study design
- This is a Phase 1 study, which means it's one of the first times this drug is being tested in people. It will include about 86 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Safety will be assessed for up to 30 months during the study.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A First-In-Human, Phase 1 Study Evaluating Oral TACC3 PPI Inhibitor, AO-252, in Advanced Solid Tumors With or Without Brain Metastases
At a glance
Conditions
Where it's being run
6 sites across 5 statesWho to contact
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What this trial measures
- Safety Assessments [Dose escalation]12 months
Incidence of Dose Limiting Toxicities (DLTs) in DLT-evaluable subjects
- Safety Assessments [Dose escalation]12 months
Identify the maximum tolerated dose and the doses for expansion
- Safety Assessments [Dose escalation and Dose expansion]30 months
Number of participants with Serious Adverse Events (SAEs) graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0
- Safety Assessments [Dose escalation and Dose expansion]30 months
Number of participants with Treatment-related Adverse Events (AEs) graded per NCI-CTCAE version 5.0
- Safety Assessments [Dose escalation and Dose expansion]30 months
Number of participants with Treatment-Emergent AEs (TEAEs) graded per NCI-CTCAE version 5.0
- Safety Assessments [Dose escalation and Dose expansion]30 months
Number of participants with Dose Interruptions and Permanent Treatment Discontinuations