Actively Recruiting
A Phase 1, Open-Label Study Evaluating AO-252, a TACC3 Protein-Protein Interaction Inhibitor, in Patients With Advanced Solid Tumors With or Without Brain Metastases
Led by A2A Pharmaceuticals Inc. · Updated on 2025-10-01
86
Participants Needed
5
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating AO-252, an oral drug that inhibits TACC3 protein-protein interactions, in adults with advanced solid tumors, including those with brain metastases. This early phase 1 trial aims to determine the safety, tolerability, and best dose of AO-252, while also studying how the drug behaves in the body and its preliminary effects on tumors. Participants include those with tumors that have TP53 mutation or loss and who have received prior treatments. The study has two parts: a dose escalation phase where participants receive increasing doses of AO-252 to find the maximum tolerated dose, followed by a dose expansion phase where more participants receive the recommended dose. AO-252 is given daily by mouth in tablet or capsule form. Patients with certain prostate cancers or brain metastases meeting specific criteria are included. The trial excludes those with symptomatic brain metastases needing immediate treatment or other significant health issues. During the study, participants will undergo safety assessments over 12 to 30 months, along with evaluations of tumor response and drug levels in the body. Researchers will use imaging and other tests to measure tumor changes based on established criteria. Participants must meet health requirements including adequate organ function and performance status. Those eligible will provide informed consent and are monitored closely throughout the trial period to assess safety and treatment effects.
CONDITIONS
Brief Title
A First-In-Human, Phase 1 Study Evaluating Oral TACC3 PPI Inhibitor, AO-252, in Advanced Solid Tumors With or Without Brain Metastases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years of age or older
- Histologically or cytologically confirmed metastatic or locally advanced unresectable solid tumors with TP53 mutation or loss
- Patients with relapsed or refractory disease after at least one prior systemic therapy (excluding melanoma)
- Specific criteria for prostate cancer patients including confirmed adenocarcinoma, PSA 6 2 ng/mL, castration status, and prior therapies
- Patients with brain metastases meeting defined size and treatment status criteria
- Measurable disease by RECIST v1.1 or PCWG-3 criteria
- Adequate bone marrow, liver, kidney, and cardiac function
- Female patients of child-bearing potential must have negative pregnancy test and use effective contraception
- Male patients must be sterilized or use barrier contraception during and for 3 months after treatment
- Life expectancy of 3 months or more
- Ability to provide written informed consent
- ECOG performance status of 0 or 1
You will not qualify if you...
- Symptomatic brain metastases requiring immediate treatment or leptomeningeal disease
- History of other malignancies within 3 years except certain cured skin or in-situ cancers
- Uncontrolled pleural, pericardial effusions, or ascites
- Gastrointestinal conditions preventing oral medication intake
- Pregnant or breastfeeding patients or those not using adequate contraception
- Known HIV, active hepatitis B or C infections unless treated and controlled
- Serious systemic disorders judged incompatible with study participation
- Recent radiation therapy to over 30% of bone marrow
- Clinically significant autoimmune disease requiring systemic immunosuppressive therapy
- Abnormal ECG including QTcF > 470 msec
- Recent systemic anticancer therapy within 3 weeks or 5 half-lives
- Unresolved adverse events from prior therapies above Grade 1
- Use of strong or moderate CYP3A4 inhibitors or inducers within 14 days prior to study drug start
- Other conditions as determined by investigator that may interfere with study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 30 months
Participants receive the oral drug AO-252 daily to evaluate safety, tolerability, and anti-tumor activity.
Regular visits throughout treatment for safety and activity assessments
Trial Site Locations
Total: 5 locations
1
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Actively Recruiting
2
Oklahoma Univeristy
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
3
Mary Crowley Cancer Research
Dallas, Texas, United States, 75230
Actively Recruiting
4
The University of Texas M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
5
Next Oncology -Virginia
Fairfax, Virginia, United States, 22031
Actively Recruiting
Research Team
R
Robbin Frnka, Chief ClinOps Officer
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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