NCT07369505 Sapu003 in Advanced mTOR-sensitive Solid Tumors
| NCT ID | NCT07369505 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | SAPU NANO (US) LLC |
| Condition | Breast Cancer Metastatic |
| Study Type | INTERVENTIONAL |
| Enrollment | 27 participants |
| Start Date | 2025-12-15 |
| Primary Completion | 2026-06 |
Trial Parameters
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
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 \[HCC\]).
Eligibility Criteria
Inclusion Criteria: 1. Sex and Age: Patients must be ≥ 18 years of age at the time of informed consent. * Cohort A (HR+/HER2- breast cancer): Eligible patients must be postmenopausal women, defined as women ≥ 18 years of age with amenorrhea for ≥ 12 consecutive months without another pathophysiological cause. * Cohort B (RCC, NETs, TSC-associated tumors, HCC): Eligible patients include both male and female adults with advanced disease. 2. Cohort A HR+/HER2- Breast Cancer: Eligible patients must meet all of the following: * Has histologically or cytologically documented advanced (metastatic or unresectable) hormone receptor-positive, HER2 negative breast cancer (advanced HR+ BC) * Has stage IV or locally advanced breast cancer per the American Joint Committee on Cancer (AJCC) Cancer Staging Manual, Seventh Edition; * Has failed any combination endocrine therapy or relapse within 6 months of adjuvant chemotherapy for metastatic or locally advanced disease. Prior therapy should have inclu
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.