Study of the PI3K Inhibitor SL-901 in Patients With Advanced Solid Tumors

Study STML-901-0119 was a multi-center, open-label, dose-escalation, and regimen-finding study aimed to investigate the safety, pharmacokinetics (PK), and pharmacodynamics of SL-901 in patients with advanced solid tumors. This study initially included two parts: Part 1a, which used a 3+3 dose-escalation design to determine the maximum tolerated dose and an appropriate dosing regimen of SL-901 when administered on both once-daily (QD) and twice-daily (BID) schedules; Part 1b, which was intended to evaluate the clinical activity of SL-901 at the selected dose in patients with advanced solid tumors with specific genetic alterations.

The study was stopped after careful consideration of the landscape of similar drugs and evolving standard of care. As a result, Part 1b was not initiated. In Part 1a, eligible patients were enrolled to receive SL-901 orally on a 28-day cycle. Study enrollment was conducted in 2 centers in the United Kingdom, and patients were assigned to either the QD or BID dosing regimen based on their cohort assignment.