Trials / Recruiting
RecruitingNCT07369505
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)
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 27 (estimated)
- Sponsor
- SAPU NANO (US) LLC · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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 \[HCC\]).
Detailed description
The study will include two cohorts: * Cohort A: Patients with HR+/HER2-negative breast cancer who will receive Sapu003 in combination with exemestane. * Cohort B: Patients with RCC, NETs, TSC-associated tumors, or HCC who will receive Sapu003 without exemestane. The dose levels planned for this study are 5 mg/m², 7.5 mg/m², and 10 mg/m² administered as weekly 30-minute IV infusions, with each treatment cycle lasting 4 weeks (28 days). The primary purpose of this study is to determine the maximum tolerated dose (MTD) of weekly intravenous Sapu003. Secondary objectives include characterizing the pharmacokinetic profile of Sapu003, evaluating its safety and tolerability, and assessing preliminary antitumor activity.
Conditions
- Breast Cancer Metastatic
- Renal Cell Carcinoma (RCC)
- Neuroendocrine Tumors
- Tuberous Sclerosis Complex (TSC)
- Hepatocellular Carcinoma (HCC)
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Sapu003 | Sapu003 weekly IV at 5, 7.5 or 10 mg/m² |
| DRUG | Exemestane 25 MG | Exemestane 25 mg QD (Breast Cancer Only) |
Timeline
- Start date
- 2025-12-15
- Primary completion
- 2026-06-01
- Completion
- 2026-12-01
- First posted
- 2026-01-27
- Last updated
- 2026-01-27
Locations
1 site across 1 country: Australia
Source: ClinicalTrials.gov record NCT07369505. Inclusion in this directory is not an endorsement.