Intravenous Treatment Targets mTOR Tumors
Sapu Nano has initiated its Phase 1b clinical trial for Sapu003, with the first patient receiving the intravenous Deciparticle formulation of everolimus on 13th May in San Diego.
Designated as SP-03-B101, the trial aims to assess the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of Sapu003 in treating advanced mTOR-sensitive solid tumors. Weekly 30-minute intravenous infusions are administered over four-week cycles.
Enrolling two cohorts, the study includes Cohort A with HR-positive/HER2-negative breast cancer patients receiving Sapu003 alongside endocrine therapy. Meanwhile, Cohort B involves patients with renal cell carcinoma, neuroendocrine tumors, TSC-associated tumors, or hepatocellular carcinoma, treated with Sapu003 monotherapy.
Using a Bayesian Optimal Interval design, the study plans dose escalation at levels of 5 mg/m², 7.5 mg/m², and 10 mg/m². An optional lower dose of 3.5 mg/m² is available if needed for safety considerations.
“This first-patient-dosed milestone represents an important step in advancing Sapu003 from clinical readiness into active patient treatment,” stated Dr. Vuong Trieu, CEO of Sapu Nano.
Everolimus, a validated mTOR inhibitor with established activity across multiple cancers, faces limitations in oral delivery due to variable absorption and dose-limiting toxicity. Sapu003 was designed to re-engineer everolimus as a weekly IV Deciparticle formulation, aiming to improve exposure control and expand the therapeutic potential of mTOR inhibition.
The Sapu003 programme was featured at the 2025 San Antonio Breast Cancer Symposium, held December 9–12, 2025, highlighting its potential impact in oncology.
The development of Sapu003 involves collaboration with the Southern Oncology Clinical Research Unit, iNGENū CRO, and Shanghai Medicilon. These partnerships support clinical, translational, pharmacokinetic, and manufacturing aspects.
Following the study’s initiation, further updates on the trial’s progress and results are anticipated as the study continues to enroll and treat patients. Research aims to unlock new clinical potential for established and novel therapeutics, focusing primarily on oncology.
Last updated: 14 May 2026, 4:36 am
