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.
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).
mCRPC with histologic confirmation of adenocarcinoma. mCRPC with neuroendocrine features or mixed histology are excluded
Patients will be enrolled irrespective of the TP53 status
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).
Sequential
AO-252
DrugAO-252 will be administered oral tablets or capsules daily
Safety Assessments [Dose escalation]
Incidence of Dose Limiting Toxicities (DLTs) in DLT-evaluable subjects
Safety Assessments [Dose escalation]
Identify the maximum tolerated dose and the doses for expansion
Safety Assessments [Dose escalation and Dose expansion]
Number of participants with Serious Adverse Events (SAEs) graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0
Safety Assessments [Dose escalation and Dose expansion]
Number of participants with Treatment-related Adverse Events (AEs) graded per NCI-CTCAE version 5.0
Antitumor Activity of AO-252 [Dose escalation and Dose expansion]
Determine the objective response rate (ORR) based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Antitumor Activity of AO-252 [Dose escalation and Dose expansion]
Determine the disease control rate (DCR) based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Antitumor Activity of AO-252 [Dose escalation and Dose expansion]
Determine the time to response (TTR) based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Antitumor Activity of AO-252 [Dose escalation and Dose expansion]
Determine the time to progression (TTP) based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
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