Sapu Nano Announces First Patient Dosed in Phase 1b Trial of Sapu003, an Intravenous Deciparticle™ Formulation of Everolimus
First-in-human study evaluates weekly IV Sapu003 in advanced mTOR-sensitive solid tumors, including HR+/HER2- breast cancer, RCC, NETs, TSC-associated tumors, and HCC
Excerpt from the Press Release:
SAN DIEGO, Calif., May 13, 2026 (GLOBE NEWSWIRE) — Sapu Nano today announced that the first patient has been dosed in the Phase 1b clinical trial of Sapu003, the Company’s investigational intravenous Deciparticle™ formulation of everolimus.
The trial: SP-03-B101 — Sapu003 in Patients with Advanced mTOR-sensitive Solid Tumors (NCT07369505), is a Phase 1b, open-label, dose-escalation trial designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of Sapu003 in patients with advanced mTOR-sensitive solid tumors. The investigational product is administered intravenously over 30 minutes once weekly in 4-week cycles.
The study includes two cohorts. Cohort A enrolls patients with HR-positive/HER2-negative breast cancer, receiving Sapu003 in combination with endocrine therapy. Cohort B enrolls patients with renal cell carcinoma, neuroendocrine tumors, TSC-associated tumors, or hepatocellular carcinoma, receiving Sapu003 as monotherapy. Dose escalation follows a Bayesian Optimal Interval design, with planned dose levels of 5 mg/m², 7.5 mg/m², and 10 mg/m², and an optional lower dose cohort of 3.5 mg/m² if required for safety.
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