OncRef

Clinical Trial: NCT07369505

Sapu003 in Advanced mTOR-sensitive Solid Tumors

Status:

RECRUITING

Phase:

Phase 1

Lead Sponsor:SAPU NANO (US) LLC
Information Provided By:SAPU NANO (US) LLC
Last Update Posted:2026-01-27

Study Overview

Brief 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]).

Official Title

A Phase 1b, Open-Label, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics of Sapu003 in Advanced mTOR-sensitive Solid Tumors (With or Without Exemestane)

Conditions

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

Intervention / Treatment

  • Drug: Sapu003
  • Drug: Exemestane 25 MG

Other Study ID Numbers

  • SP-03-B101

Start Date (Actual)

2025-12-15

Primary Completion Date (Estimated)

2026-06

Study Completion Date (Estimated)

2026-12

Enrollment (Estimated)

27

Study Type

Interventional

Phase

Phase 1