RecruitingPhase 3NCT06828354

A Study of SHR-A1811 in Subjects With Ovarian Cancer

An Open-label, Randomized, Multicenter Phase III Clinical Trial of SHR-A1811 Versus Investigator-selected Chemotherapy for Platinum-resistant Relapsed Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer


Sponsor

Jiangsu HengRui Medicine Co., Ltd.

Enrollment

300 participants

Start Date

Mar 13, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This is an open-label study to evaluate the safety and efficacy of SHR-A1811 for injection in subjects with ovarian cancer.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing SHR-A1811 — an antibody-drug conjugate that delivers chemotherapy directly to cancer cells — in people with ovarian cancer. The drug targets HER2, a protein present on some ovarian cancer cells, and is designed to kill them while minimizing damage to healthy tissue. **You may be eligible if...** - You have ovarian cancer with at least one measurable tumor on a scan - You are in good overall health (ECOG performance status 0 or 1) - Your expected survival is at least 12 weeks **You may NOT be eligible if...** - You have active brain metastases causing symptoms that have not been treated - You have serious, uncontrolled heart disease - You have an active autoimmune disease or a history of one - You currently have active hepatitis B or hepatitis C - You have a severe active infection 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.

DRUGPaclitaxel Injection

Paclitaxel Injection.

DRUGDoxorubicin Hydrochloride Liposome Injection

Doxorubicin Hydrochloride Liposome Injection.

DRUGGemcitabine Hydrochloride for Injection

Gemcitabine Hydrochloride for Injection.

DRUGTopotecan Hydrochloride for Injection

Topotecan Hydrochloride for Injection.


Locations(2)

Tongji Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Qilu Hospital of Shandong University

Jinan, Shandong, China

View Full Details on ClinicalTrials.gov

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NCT06828354


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