Status: Recruiting
Sapu003 in Advanced mTOR-sensitive Solid Tumors
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 \[HCC\]).
Participants needed: 27
Trial details
Phase: Phase 1Age: 18+Biological sex: AllType: InterventionalSponsor: SAPU NANO (US) LLCUpdated: Jan 27, 2026Locations: 1
Eligibility criteria
Sex and Age: Patients must be ≥ 18 years of age at the time of informed consent. [+28]
Patients with a history of other malignancies, except for adequately treated non... [+18]