RecruitingPhase 2NCT07051486

A Phase II Trial of SHR-A1811 in HER2-Expressing Recurrent/Metastatic Cervical Cancer

A Single-Arm, Multicenter Phase II Clinical Trial of SHR-A1811 for Injection in Patients With HER2-Expressing Recurrent or Metastatic Cervical Cancer Progressing After Standard Treatment


Sponsor

Jiangsu HengRui Medicine Co., Ltd.

Enrollment

60 participants

Start Date

Oct 11, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This study is a single-arm, multicenter Phase II clinical trial of SHR-A1811 for injection in patients with HER2-expressing recurrent or metastatic cervical cancer who have failed prior systemic therapy.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This Phase II trial tests a targeted antibody-drug therapy called SHR-A1811 in women with recurrent or metastatic cervical cancer whose tumors express HER2 — a protein found on the surface of some cancer cells. The drug is designed to deliver chemotherapy directly to cancer cells. **You may be eligible if:** - You are a woman between 18 and 75 years old with pathology-confirmed cervical cancer - Your cancer has come back or spread and you have received prior treatment - You have adequate organ function (blood counts, kidney, liver, heart) - Your expected survival is at least 12 weeks - You agree to use effective contraception and are not breastfeeding **You may NOT be eligible if:** - You have untreated or active brain metastases - You have had another type of cancer - You have uncontrolled fluid around the lungs or heart - You have a history of interstitial lung disease or serious lung inflammation - You have poorly controlled heart disease or recent blood clots - You have had a serious infection within the past month - You have a history of HIV or immunodeficiency 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 Injection

SHR-A1811 for injection.


Locations(2)

Fujian Cancer Hospital

Fuzhou, Fujian, China

Shandong University Qilu Hospital

Jinan, Shandong, China

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NCT07051486


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