RecruitingBreast Cancer MetastaticRenal Cell Carcinoma (RCC)Neuroendocrine Tumors
Sapu003 in Advanced mTOR-sensitive Solid Tumors
Eligible age
18+ yrs
Accepts
All genders
Locations
0 states
Healthy volunteers
No
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About this study
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 \[HCC\]).
Sponsor: SAPU NANO (US) LLC
You may qualify if…
- ✓ 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 included a non-steroidal aromatase inhibitor unless clinically contraindicated;
You may not qualify if…
- ✕ 1. Patients with a history of other malignancies, except for adequately treated non-melanoma skin cancer, curatively treated in-situ carcinoma of the cervix, curatively treated in-situ carcinoma of the breast, or other solid tumors curatively treated with no evidence of disease for \> 5 years.
- ✕ 2. Patients who have not completely recovered from any toxicities from previous chemotherapy, hormone therapy, immunotherapy, target therapy, or radiotherapies ≥ Grade 1 per NCI CTCAE version 5.0, with the exception of alopecia.
- ✕ 3. Patients who have received any of the following treatments within the specified timeframes prior to screening:
- ✕ Prior chemotherapy within 30 days prior to screening (42 days for mitomycin C or nitrosoureas).
- ✕ Prior immunotherapy, prior anti-tumor hormonal therapy (for breast cancer patients), and prior radiotherapy within 30 days prior to screening.
- ✕ Radiotherapy is not allowed during study. Administration of other chemotherapy, immunotherapy, or anti-tumor hormonal therapy during the study is not allowed.
- ✕ 4. Patients had major surgery within 30 days prior to randomization, or patients have not recovered from prior major surgery.
- ✕ 5. Sensory / Peripheral neuropathy of \> Grade 1 per NCI CTCAE version 5.0 at Screening.
Source: ClinicalTrials.gov · NCT07369505 · last updated 2026-01-27