Clinical Trial

Sapu003 in Advanced mTOR-sensitive Solid Tumors

Recruiting Phase 1
View on ClinicalTrials.gov →
Record status
This record was last updated January 27, 2026 (before its estimated June 2026 completion). Its status may not reflect the trial's current state.
Summary
This is a phase 1b, open-label, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics of Sapu003 in combination with Exemestane in in patients with advanced mTOR-sensitive solid tumors (HR+/HER2-negative breast cancer, renal cell carcinoma \[RCC\], neuroendocrine tumors \[NETs\], tuberous sclerosis complex \[TSC\]-associated tumors, and hepatocellular carcinoma \[HCC\]).
Trial Details
NCT Number NCT07369505
Lead Sponsor SAPU NANO (US) LLC
Conditions Breast Cancer Metastatic, Renal Cell Carcinoma (RCC), Neuroendocrine Tumors, Tuberous Sclerosis Complex (TSC), Hepatocellular Carcinoma (HCC)
Enrollment 27 participants
Start Date 2025-12-15
Primary Completion 2026-06 (estimated)
Study Completion 2026-12 (estimated)
Updated on ClinicalTrials.gov 2026-01-27