Sapu003 in Advanced mTOR-sensitive Solid Tumors

Sponsor
SAPU NANO (US) LLC
Study ID
NCT07369505
Phase
PHASE1
Status
Recruiting
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Conditions

  • Breast Cancer Metastatic
  • Hepatocellular Carcinoma (HCC)
  • Neuroendocrine Tumors
  • Renal Cell Carcinoma (RCC)
  • Tuberous Sclerosis Complex (TSC)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Sapu003 — DRUG
    Sapu003 weekly IV at 5, 7.5 or 10 mg/m²
  • Exemestane 25 MG — DRUG
    Exemestane 25 mg QD (Breast Cancer Only)

Study Details

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 \[HCC\]).

Key Dates

First listed
Jan 27, 2026
Start date
Dec 15, 2025
Status verified
Jan 2026
Primary completion
Jun 30, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
27 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort A - HR+/HER2- Breast Cancer
    Cohort A (Combination Therapy - HR+/HER2- Breast Cancer): Post-menopausal women with advanced or metastatic hormone-receptor-positive, HER2-negative breast cancer receive Sapu003 (everolimus for injection) as a 30-min IV infusion once weekly at 5, 7.5 or 10 mg/m², together with oral exemestane 25 mg once daily, repeated in 28-day cycles.
  • Experimental: Cohort B - RCC / NET / TSC / HCC
    Cohort B (Monotherapy - RCC / NET / TSC / HCC): Adult patients with advanced renal cell carcinoma, neuro-endocrine tumours, tuberous-sclerosis-complex-associated tumours, or hepatocellular carcinoma receive Sapu003 (everolimus for injection) alone as a 30-min infusion once weekly at 5, 7.5 or 10 mg/m², repeated in 28-day cycles.

Primary Outcome Measure

Maximum Tolerated Dose (MTD) and Dose Limiting Toxicities (DLTs) of Sapu003 in Patients with Advanced mTOR-Sensitive Solid Tumors [ Time Frame: The primary outcome timeframe is assessed during the first 28-day cycle of treatment, specifically looking at dose-limiting toxicities (DLTs) to determine the maximum tolerated dose (MTD) of Sapu003 ]

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