RecruitingPhase 1NCT06136884

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


Sponsor

A2A Pharmaceuticals Inc.

Enrollment

86 participants

Start Date

Nov 2, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This is a first-in-human Phase 1 study testing a new oral drug called AO-252 in people with advanced solid tumors. The drug is designed to target a protein called TACC3, which plays a role in cancer cell growth. It also accepts patients whose cancer has spread to the brain. **You may be eligible if...** - You are 18 or older - You have an advanced solid tumor (most types, not melanoma) that has a TP53 gene mutation or loss, and your cancer has stopped responding to at least one prior treatment - You have castration-resistant prostate cancer (mCRPC) that has progressed after hormone therapy and/or chemotherapy - Your cancer may or may not have spread to the brain - You have adequate blood counts, liver, kidney, and heart function - Your overall health is good (ECOG performance status 0–1) - You have a life expectancy of at least 3 months **You may NOT be eligible if...** - Your brain metastases are causing symptoms that need immediate treatment - You have had another cancer in the last 3 years (other than treated skin cancer) - You have uncontrolled fluid buildup around the lungs or abdomen - You cannot swallow pills or have serious gut problems that affect absorption - You are pregnant or breastfeeding - You have active HIV, hepatitis B, or hepatitis C - You have significant heart rhythm problems - You took strong CYP3A4-affecting drugs within the last 14 days Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAO-252

AO-252 will be administered oral tablets or capsules daily


Locations(5)

Karmanos Cancer Institute

Detroit, Michigan, United States

Oklahoma Univeristy

Oklahoma City, Oklahoma, United States

Mary Crowley Cancer Research

Dallas, Texas, United States

The University of Texas M.D. Anderson Cancer Center

Houston, Texas, United States

Next Oncology -Virginia

Fairfax, Virginia, United States

View Full Details on ClinicalTrials.gov

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NCT06136884


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