OncoMatch/Clinical Trials/NCT07369505
Sapu003 in Advanced mTOR-sensitive Solid Tumors
Is NCT07369505 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including Sapu003 and Exemestane 25 MG for breast cancer metastatic.
Treatment: Sapu003 · Exemestane 25 MG — 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 \[HCC\]).
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Renal Cell Carcinoma
Neuroendocrine Tumor
Hepatocellular Carcinoma
Disease stage
Required: Stage IV, III
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: endocrine therapy (non-steroidal aromatase inhibitor)
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
Must have received: standard therapy
Has progressed on or is intolerant to at least one prior line of standard therapy appropriate for the specific tumor type, unless no effective standard therapy exists
Cannot have received: chemotherapy (mitomycin C, nitrosoureas)
Prior chemotherapy within 30 days prior to screening (42 days for mitomycin C or nitrosoureas)
Cannot have received: immunotherapy
Prior immunotherapy...within 30 days prior to screening
Cannot have received: anti-tumor hormonal therapy
prior anti-tumor hormonal therapy (for breast cancer patients)...within 30 days prior to screening
Cannot have received: radiation therapy
prior radiotherapy within 30 days prior to screening. Radiotherapy is not allowed during study.
Lab requirements
Blood counts
Absolute neutrophil count (ANC) ≥ 2,000 cells/mm3; Platelet count ≥ 100,000 cells/mm3; Hemoglobin ≥ 9 g/dL
Kidney function
Serum creatinine ≤ 1.5 x ULN; GFR ≥ 50 mL/min/1.73m2 by the CKD-EPI or MDRD formulas.
Liver function
Total bilirubin ≤1.5 x ULN or direct bilirubin ≤1 x ULN for patients with total bilirubin levels > 1.5 ULN; AST (SGOT) / ALT (SGPT) ≤ 2.5 x ULN (≤5 x ULN for patients with metastases.)
Patient has adequate hematological, renal, and hepatic function as defined by the following Screening laboratory values obtained within 7 days prior to randomization and assessed based on local labs
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify