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Oral Tablet AP23573 Clinical Trial – Objectives

This clinical trial investigates the safety, tolerability, and maximum tolerated dose (MTD) of oral AP23573 in multiple dosing schedules. It compares the pharmacokinetics and anti-tumor activity of oral administration with intravenous outcomes. Over 125 patients, primarily with sarcoma, have been treated, revealing evidence of mTOR inhibition and prolonged stable disease in many cases. The trial assesses side effects, with the most notable being mouth sores. The final dosing regimen is being optimized for maximum efficacy and tolerability.

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Oral Tablet AP23573 Clinical Trial – Objectives

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  1. Oral Tablet AP23573 Clinical Trial – Objectives • Primary • Determine safety, tolerability and MTD of multiple dose schedules of oral AP23573 studied in parallel • Secondary • Compare blood levels to those in the intravenous program showing anti-tumor activity • Confirm mTOR inhibition by PD assays • Describe anti-tumor activity • Characterize PK parameters Confidential

  2. Oral AP23573 Trial Status • 7 dose schedules studied in parallel • MTD identified • Over 125 patients treated • Majority of patients with a diagnosis of sarcoma • Evidence of mTOR inhibition using pharmacodynamic assay • Many patients with prolonged stable disease • On study 4-15+ months • Side effect profile consistent with i.v. • Mouth sores main DLT • Final dose schedule being optimized for highest cumulative dose and frequency of dosing together with tolerability to allow long-term use Confidential

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