Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 11:56 AM
Study NCT ID:
NCT07369505
Status:
RECRUITING
Last Update Posted:
2026-01-27
First Post:
2026-01-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sapu003 in Advanced mTOR-sensitive Solid Tumors
Sponsor:
SAPU NANO (US) LLC
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2026-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
* 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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: