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New treatment option for Solid Tumor Malignancies
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
ClinicalTrials.gov ID: NCT06136884
What this study is testing
What is AO-252?
AO-252 is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for solid tumor malignancies.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Adults ≥ 18 years of age.
- Patient has histologically or cytologically confirmed metastatic or locally advanced unresectable solid tumors with TP53 mutation/loss and...
- Prostate cancer:
- mCRPC with histologic confirmation of adenocarcinoma. mCRPC with neuroendocrine features or mixed histology are excluded
- Patients will be enrolled irrespective of the TP53 status
You likely can't join if
- Patients with symptomatic brain metastases requiring treatment and/or leptomeningeal disease
- Patients with a previous history of another malignancy (other than cured basal cell or squamous cell carcinoma of the skin or cured in-situ...
- Patients with uncontrolled pleural effusions, pericardial effusion, or ascites that do not resolve.
- Patients with gastrointestinal tract disease causing the inability to take oral medication (e.g., swallowing difficulties, malabsorption syndromes...
- Pregnant or breast-feeding patients or any patient with child-bearing potential not using adequate contraception.
- Known human immunodeficiency virus, hepatitis B virus (HBV), or hepatitis C virus (HCV) infection (excluding cured HBV and/or cured HCV infection).
See the full eligibility criteria
- Adults ≥ 18 years of age.
- Patient has histologically or cytologically confirmed metastatic or locally advanced unresectable solid tumors with TP53 mutation/loss and with/without brain metastasis. Patients must have relapsed/be refractory to at...
- Prostate cancer:
- mCRPC with histologic confirmation of adenocarcinoma. mCRPC with neuroendocrine features or mixed histology are excluded
- Patients will be enrolled irrespective of the TP53 status
- Participant must have prostate specific antigen (PSA) of ≥ 2 ng/mL
- Is surgically or medically castrated, with testosterone levels of less than 50 ng/dL
- Patients who progressed on at least 1 prior novel androgen receptor AR-targeted therapy (that is, abiraterone acetate, apalutamide, enzalutamide, darolutamide), and or at least 1 prior systemic chemotherapy (e.g...
- Solid tumors with brain metastasis:
- Histologically or cytologically confirmed metastatic or locally advanced unresectable solid tumors excluding melanoma with TP53 mutation/loss and tumor must have relapsed/be refractory to at least 1 line of systemic...
- Previously treated brain metastases with progression of previous lesions or new lesions, but not requiring immediate local CNS therapy
- At least one measurable untreated brain lesion ≥0.5 cm and \<3.0 cm in the longest axis
- Prior SRS radiosurgery (must be completed within 7 days of study treatment initiation) is allowed as long as the previous treatment volume does not overlap with the current targets.
- Measurable disease per RECIST v1.1 criteria. For mCRPC patients, tumor response will be evaluated using RECIST version 1.1 (soft tissue) and PCWG-3 criteria (bone) and how well it works endpoints will also include...
- Adequate bone marrow reserve, cardiac, liver, and renal function:
- Absolute neutrophil count (ANC) ≥ 1,500/mm3
- Platelet count ≥ 100,000/mm3
- Hemoglobin ≥ 9 g/dL
- Bilirubin ≤ 1.5 × upper limit of normal (ULN) or direct bilirubin ≤ ULN for patients with total bilirubin levels \>1.5 × ULN
- Alanine aminotransferase (ALT, SGPT) and aspartate aminotransferase (AST, SGOT) ≤ 2.5 × ULN (≤ 5 × ULN if liver metastases are present)
- INR ≤ 1.5 × ULN unless patient is receiving anticoagulant therapy and PT or aPTT is within therapeutic range of intended use of anticoagulants
- Creatinine clearance ≥ 60 mL/min (by Cockroft Gault formula).
- Female patients of child-bearing potential must have a negative serum pregnancy test and use at least 1 form of acceptable birth control method listed below as approved by the Investigator before initiating study...
- Sterilization
- Any hormonal contraceptives (non-CYP 3A4 inhibitors) associated with inhibition of ovulation
- IUD (intrauterine device) or intrauterine hormone releasing system
- Male patients must be sterilized or use a form of barrier contraception, such as condoms with spermicide, during the study and for 3 months after the last dose of study drug.
- Life expectancy of ≥ 3 months.
- Ability to provide written informed consent.
- An Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1.
- Patients with symptomatic brain metastases requiring treatment and/or leptomeningeal disease
- Patients with a previous history of another malignancy (other than cured basal cell or squamous cell carcinoma of the skin or cured in-situ carcinoma) within 3 years of study entry.
- Patients with uncontrolled pleural effusions, pericardial effusion, or ascites that do not resolve.
- Patients with gastrointestinal tract disease causing the inability to take oral medication (e.g., swallowing difficulties, malabsorption syndromes, extensive small bowel resection [\> 100cm], gastric bypass surgery).
- Pregnant or breast-feeding patients or any patient with child-bearing potential not using adequate contraception.
- Known human immunodeficiency virus, hepatitis B virus (HBV), or hepatitis C virus (HCV) infection (excluding cured HBV and/or cured HCV infection).
- Presence of any serious concomitant systemic disorders incompatible with the study in the opinion of the Investigator (e.g., uncontrolled congestive heart failure, active infection).
- Radiation therapy to \> 30% of bone marrow within 3 months before study entry.
- Patients with clinically significant autoimmune disease, either currently present of present within 2 years, including a current requirement for systemic immunosuppressive therapy equivalent to \> 10 mg/prednisone daily...
The study team makes the final eligibility decision.
Where it's taking place
- Detroit, Michigan, United States
- Oklahoma City, Oklahoma, United States
- Charleston, South Carolina, United States
- Dallas, Texas, United States
- Houston, Texas, United States
- Fairfax, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Detroit, Michigan, United States; Oklahoma City, Oklahoma, United States; Charleston, South Carolina, United States; Dallas, Texas, United States; Houston, Texas, United States; Fairfax, Virginia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.