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A Phase 1b, Open-Label, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics of Sapu003 in Combination with Exemestane in Post-Menopausal Women with Hormone Receptor-Positive, HER2-Negative Advanced or Metastatic Breast Cancer After Progression on a Non-Steroidal Aromatase Inhibitor.

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Trial Profile

A Phase 1b, Open-Label, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics of Sapu003 in Combination with Exemestane in Post-Menopausal Women with Hormone Receptor-Positive, HER2-Negative Advanced or Metastatic Breast Cancer After Progression on a Non-Steroidal Aromatase Inhibitor.

Status: Recruiting
Phase of Trial: Phase I

Latest Information Update: 12 Nov 2025

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At a glance

  • Drugs Everolimus (Primary) ; Exemestane (Primary)
  • Indications Advanced breast cancer; HER2 negative breast cancer; Neuroendocrine tumours; Renal cell carcinoma
  • Focus Adverse reactions; First in man
  • Sponsors Oncotelic Therapeutics - Dragon Overseas Capital (JV)

Most Recent Events

  • 06 Nov 2025 New trial record
  • 23 Oct 2025 According to a Sapu Nano media release, three abstracts supporting this Phase 1 trial of Sapu003 in hormone receptor-positive (HR)/HER2 metastatic breast cancer have been accepted for presentation at the 2025 San Antonio Breast Cancer Symposium (SABCS), to be held December 9-12, 2025, at the Henry B. Gonzalez Convention Center, San Antonio, Texas.
  • 08 Oct 2025 Status changed from not yet recruiting to recruiting according to a Sapu Nano media release.

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