{"entity":{"id":"sapu-003","kind":"drug","name":"Sapu003 (SAPU-003, everolimus Deciparticle)","aka":["SAPU-003","Sapu003","Sapu 003","Sapu003/Everolimus for Injection"],"tldr":"Sapu003 (SAPU-003, everolimus Deciparticle) is an experimental sub-20 nm nanoparticle intravenous formulation of everolimus from Sapu Nano, in phase 1 trials for HR-positive HER2-negative metastatic breast cancer, renal cell carcinoma and neuroendocrine tumours and other cancers.","summary":"Sapu003 (SAPU-003, everolimus Deciparticle) (SAPU-003, Sapu003, Sapu 003) is a sub-20 nm nanoparticle (Deciparticle) intravenous formulation of everolimus from Sapu Nano. An intravenous Deciparticle formulation of the mTOR inhibitor everolimus, given weekly. The company says it bypasses gut metabolism and gives full exposure to both mTOR complexes. Its furthest stage is phase 1, for HR-positive HER2-negative metastatic breast cancer, renal cell carcinoma, neuroendocrine tumours and tuberous sclerosis complex-associated tumours. ClinicalTrials.gov registers it in one study linked below. Registry lists NCT07369505 as phase 1, recruiting (start 2025-12-15, actual); the company pipeline table says 'Phase 1/2' and its 13 May 2026 release says first patient dosed in the phase 1b trial. Whether it works in people has not been established unless a trial below reports it.","status":"phase-1","asOf":"2026-11-03","links":[{"label":"Sapu Nano: sapunano.com","url":"https://sapunano.com/sapu003/"},{"label":"Sapu Nano: sapunano.com","url":"https://sapunano.com/sapu003/"},{"label":"Sapu Nano: sapunano.com","url":"https://sapunano.com/pipeline/"},{"label":"Sapu Nano: sapunano.com","url":"https://sapunano.com/news/"},{"label":"ClinicalTrials.gov: trials of SAPU-003","url":"https://clinicaltrials.gov/search?intr=SAPU-003"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-hr-positive","rcc","neuroendocrine","hcc"],"sections":[],"technologies":[],"targets":["mtor"],"drugs":[],"companies":["sapu-nano"],"institutions":[],"pathways":[],"terms":[],"trials":["nct07369505"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"provenance":{"editedBy":"OnCo gap audit, class 5 (company pipeline pages and ClinicalTrials.gov v2)","editedOn":"2026-11-03"},"code":"SAPU-003","modality":"Sub-20 nm nanoparticle (Deciparticle) intravenous formulation of everolimus","mechanism":"An intravenous Deciparticle formulation of the mTOR inhibitor everolimus, given weekly. The company says it bypasses gut metabolism and gives full exposure to both mTOR complexes.","approvals":[],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/sapu-003/","neighbours":{"cancer":[{"id":"hcc","kind":"cancer","name":"Hepatocellular carcinoma","route":"/cancers/hcc/"},{"id":"breast-hr-positive","kind":"cancer","name":"HR-positive / HER2-negative breast cancer","route":"/cancers/breast-hr-positive/"},{"id":"neuroendocrine","kind":"cancer","name":"Neuroendocrine tumours","route":"/cancers/neuroendocrine/"},{"id":"rcc","kind":"cancer","name":"Renal cell carcinoma","route":"/cancers/rcc/"}],"target":[{"id":"mtor","kind":"target","name":"mTOR","route":"/targets/mtor/"}],"company":[{"id":"sapu-nano","kind":"company","name":"Sapu Nano","route":"/companies/sapu-nano/"}],"trial":[{"id":"nct07369505","kind":"trial","name":"Sapu003 in Advanced mTOR-sensitive Solid Tumors","route":"/trials/nct07369505/"}]}}