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

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 ]

Central Contacts

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