A First-In-Human, Phase 1 Study Evaluating Oral TACC3 PPI Inhibitor, AO-252, in Advanced Solid Tu… (NCT06136884) | Clinical Trial Compass
RecruitingPhase 1
A First-In-Human, Phase 1 Study Evaluating Oral TACC3 PPI Inhibitor, AO-252, in Advanced Solid Tumors With or Without Brain Metastases
United States86 participantsStarted 2023-11-02
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion 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 least 1 line of systemic therapy in the metastatic setting (excluding melanoma).
✓. 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., docetaxel)
✕. 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.
What they're measuring
1
Safety Assessments [Dose escalation]
Timeframe: 12 months
2
Safety Assessments [Dose escalation]
Timeframe: 12 months
3
Safety Assessments [Dose escalation and Dose expansion]
Timeframe: 30 months
4
Safety Assessments [Dose escalation and Dose expansion]
Timeframe: 30 months
5
Safety Assessments [Dose escalation and Dose expansion]
Timeframe: 30 months
6
Safety Assessments [Dose escalation and Dose expansion]
✕. 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.