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Sapu003 in Advanced mTOR-sensitive Solid Tumors

NCT07369505 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2026-01-27

No results posted yet for this study

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 \[HCC\]).

Conditions

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

Interventions

DRUG

Sapu003

Sapu003 weekly IV at 5, 7.5 or 10 mg/m²

DRUG

Exemestane 25 MG

Exemestane 25 mg QD (Breast Cancer Only)

Sponsors & Collaborators

  • SAPU NANO (US) LLC

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-15
Primary Completion
2026-06-30
Completion
2026-12-31

Countries

  • Australia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07369505 on ClinicalTrials.gov