Sapu003 in Advanced mTOR-sensitive Solid Tumors

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 \[HCC\]).

Trial Details

NCT ID
NCT07369505
Phase
PHASE1
Sponsor
SAPU NANO (US) LLC
Status
RECRUITING
Cancer Type
ER/PR Positive (Hormone Receptor Positive) Breast Cancer
Interventions
  • Sapu003
  • Exemestane 25 MG
Locations (sample)
  • Adelaide, Australia|-34.92866,138.59863

Key Eligibility Criteria

  • Sex and Age: Patients must be ≥ 18 years of age at the time of informed consent.
  • Cohort A (HR+/HER2- breast cancer): Eligible patients must be postmenopausal women, defined as women ≥ 18 years of age with amenorrhea for ≥ 12 con…
  • Cohort B (RCC, NETs, TSC-associated tumors, HCC): Eligible patients include both male and female adults with advanced disease.
  • Cohort A HR+/HER2- Breast Cancer:

For full eligibility, visit ClinicalTrials.gov.

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