Actively Recruiting
A First-In-Human, Phase 1 Study Evaluating Oral TACC3 PPI Inhibitor, AO-252, in Advanced Solid Tumors With or Without Brain Metastases
Led by A2A Pharmaceuticals Inc. · Updated on 2025-10-01
86
Participants Needed
5
Research Sites
221 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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, with or without brain metastases
- Patients must have relapsed or be refractory to at least one line of systemic therapy in the metastatic setting (excluding melanoma)
- For prostate cancer patients: histologic confirmation of adenocarcinoma, PSA 2 ng/mL, surgically or medically castrated with testosterone <50 ng/dL, and progression after at least one prior novel androgen receptor-targeted therapy or systemic chemotherapy
- Solid tumors with brain metastases must have at least one measurable untreated brain lesion 0.5 cm and <3.0 cm in longest axis
- Measurable disease per RECIST v1.1 criteria; mCRPC patients evaluated with RECIST v1.1 (soft tissue) and PCWG-3 criteria (bone)
- Adequate bone marrow, liver, renal, and cardiac function as specified by blood counts and laboratory values
- Female patients of child-bearing potential must have a negative pregnancy test and use at least one approved birth control method
- Male patients must be sterilized or use barrier contraception during the study and for 3 months after last dose
- Life expectancy of at least 3 months
- Ability to provide written informed consent
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
You will not qualify if you...
- Symptomatic brain metastases requiring treatment or leptomeningeal disease
- History of other malignancies within 3 years except certain cured skin or in-situ carcinomas
- Uncontrolled pleural, pericardial effusions, or ascites
- Gastrointestinal conditions preventing oral medication intake
- Pregnant or breastfeeding women or patients not using adequate contraception
- Known active HIV, hepatitis B or C infections (except cured cases)
- Serious systemic disorders incompatible with study participation
- Radiation therapy to more than 30% of bone marrow within 3 months prior to study
- Clinically significant autoimmune disease requiring systemic immunosuppression above specified doses
- Abnormal or clinically significant ECG abnormalities including QTcF >470 msec
- Recent systemic anticancer therapy within 3 weeks or 5 half-lives
- Ongoing adverse events from previous therapies above grade 1
- Use of strong or moderate cytochrome 3A4 inhibitors or inducers within 14 days or 5 half-lives before study drug administration
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
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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