Sapu003 in Advanced mTOR-sensitive Solid Tumors
A Phase 1b, Open-Label, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics of Sapu003 in Advanced mTOR-sensitive Solid Tumors (With or Without Exemestane)
SAPU NANO (US) LLC
27 participants
Dec 15, 2025
INTERVENTIONAL
Conditions
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 \[HCC\]).
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
Sapu003 weekly IV at 5, 7.5 or 10 mg/m²
Exemestane 25 mg QD (Breast Cancer Only)
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07369505