RecruitingPhase 1NCT05661461

Dose-escalation Study to Assess Safety and Pharmacokinetics of Nab-Sirolimus in Patients With Locally Advanced or Metastatic Solid Tumors and Moderate Liver Impairment

A Phase 1, Open-label, Dose-escalation Study to Assess Safety and Pharmacokinetics of Nab-Sirolimus in Patients With Locally Advanced or Metastatic Solid Tumors and Moderate Liver Impairment


Sponsor

Aadi Bioscience, Inc.

Enrollment

28 participants

Start Date

Nov 23, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

This is a phase 1, multi-center, open-label, dose-escalation study of nab-sirolimus in adult patients with locally advanced or metastatic solid tumors and moderate hepatic impairment or normal hepatic function.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This is an early-phase study looking at how a drug called nab-sirolimus (an anti-cancer agent that targets cell growth pathways) behaves in the body in people with advanced solid tumors who also have moderate liver problems. Researchers want to find the right dose and understand how liver impairment affects the drug's processing. **You may be eligible if...** - You are 18 or older - You have a confirmed advanced or metastatic solid tumor (any type) - You are in reasonably good health (ECOG 0–2) - Your blood counts, kidney function, and cholesterol/triglyceride levels meet the study requirements - You may have either normal liver function or moderate liver impairment (the study has arms for each) - You are willing to use highly effective contraception if you could become pregnant **You may NOT be eligible if...** - You are pregnant or breastfeeding - Your cholesterol or triglycerides are significantly elevated - You do not have a confirmed solid tumor diagnosis - Your overall health or organ function does not meet the study's requirements 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

DRUGnab-sirolimus

This is a phase 1, multi-center, open-label, dose-escalation study of nab-sirolimus in adult patients with locally advanced or metastatic solid tumors and moderate hepatic impairment or normal hepatic function.


Locations(2)

South Texas Accelerated Research Therapeutics, LLC

San Antonio, Texas, United States

START Mountain Region

West Valley City, Utah, United States

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NCT05661461


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