drugset / Trial / NCT07369505
Sapu003 in Advanced mTOR-sensitive Solid Tumors
Non-randomizedSequentialOpen-labelTreatment
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 \[HCC\]).
Timeline
- Start
- 2025-12-15
- Primary completion
- 2026-06
- Completion
- 2026-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Exemestane | Small molecule | 25 mg | Oral |
| Subject | Sapu003 | Unknown | 3.5 mg/m2 | Intravenous |
| Subject | Sapu003 | Unknown | 5 mg/m2 | Intravenous |
| Subject | Sapu003 | Unknown | 7.5 mg/m2 | Intravenous |
| Subject | Sapu003 | Unknown | 10 mg/m2 | Intravenous |