RecruitingPhase 1NCT06710990

Investigation of Drug-drug Interaction of Ritonavir and Itraconazole on the Pharmacokinetics of SHR-A1811 in Subjects With HER2-expressing Advanced Breast Cancer

A Multicenter, Open-label, Fixed-sequence Study to Evaluate Drug-drug Interaction of Ritonavir and Itraconazole on the Pharmacokinetics of SHR-A1811 in Subjects With HER2-expressing Advanced Breast Cancer


Sponsor

Jiangsu HengRui Medicine Co., Ltd.

Enrollment

32 participants

Start Date

Feb 17, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The study is being conducted to evaluate the pharmacokinetics and safety of SHR-A1811 monotherapy and in combination with Ritonavir or Itraconazole in subjects with HER2-expressing advanced breast cancer.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study examines how two common medications (ritonavir and itraconazole) affect the levels of a cancer drug called SHR-A1811 in the body. It is enrolling women with HER2-expressing advanced breast cancer to understand potential drug interactions. **You may be eligible if...** - You have advanced breast cancer that tests positive for HER2 - You are in good general health (able to carry out normal activities) - Your blood counts, liver function, kidney function, and heart function meet the study requirements - Your expected survival is at least 3 months **You may NOT be eligible if...** - You have uncontrolled infections or serious other illnesses - Your organ function tests fall outside acceptable ranges - You have significant heart problems (low heart pumping function) 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

DRUGSHR-A1811

SHR-A1811

DRUGRitonavir

Ritonavir

DRUGItraconazole

Itraconazole


Locations(2)

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

Hunan Cancer Hospital

Changsha, Hunan, China

View Full Details on ClinicalTrials.gov

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NCT06710990


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