RecruitingPhase 1NCT07369505

Sapu003 in Advanced mTOR-sensitive Solid Tumors

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)


Sponsor

SAPU NANO (US) LLC

Enrollment

27 participants

Start Date

Dec 15, 2025

Study Type

INTERVENTIONAL

Conditions

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 \[HCC\]).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called Sapu003, which blocks a cellular signaling pathway called mTOR, in two groups of patients: postmenopausal women with hormone receptor-positive, HER2-negative advanced breast cancer (Cohort A), and adults with kidney cancer, neuroendocrine tumors, TSC-related tumors, or liver cancer (Cohort B). **You may be eligible if (Cohort A — breast cancer)...** - You are a postmenopausal woman with advanced ER+/HER2- breast cancer - Your cancer has progressed after prior hormone therapy (with or without a CDK4/6 inhibitor) - You have not previously received mTOR inhibitors **You may be eligible if (Cohort B — other cancers)...** - You are 18 or older with advanced kidney cancer, neuroendocrine tumors, TSC-associated tumors, or hepatocellular carcinoma - Your cancer has progressed on or after prior standard therapy **You may NOT be eligible if...** - You have received prior mTOR inhibitor therapy - Your organ function is too poor to tolerate treatment - You are pregnant or breastfeeding - You have uncontrolled infections or certain lung conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSapu003

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

DRUGExemestane 25 MG

Exemestane 25 mg QD (Breast Cancer Only)


Locations(1)

SOCRU

Adelaide, Australia

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NCT07369505


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