Tests SHR-A1811 in cervical cancer that has returned or spread
Tests SHR-A1811 in adults with HER2-expressing cervical cancer after prior treatment.
Plain-language title generated from the registry record
Registry title: A Phase II Trial of SHR-A1811 in HER2-Expressing Recurrent/Metastatic Cervical Cancer
Key facts
- Where
- Fuzhou and Jinan, ChinaSee the 2 sites
- Phase
- Phase 2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for women with cervical cancer that has come back or spread, and whose disease got worse after standard treatment. The cancer must express HER2.
- Age
- 18 to 75 years old
- Sex
- Women only
- Disease stage
- Cervical cancer confirmed by tissue or cell examination, recurrent or metastatic, after failed earlier systemic therapy
- Earlier treatment
- Earlier systemic therapy must have failed or the disease must have progressed after standard treatment
- Biomarker or test result
- HER2 expression
Main reasons for not taking part
- Known untreated or active tumor spread to the brain or spinal cord
- Another cancer in the past or at the same time
- Moderate or larger fluid build-up around the lungs, heart or abdomen, or causing symptoms
- History of interstitial lung disease or pneumonia needing steroids
- Positive HIV test or history of immunodeficiency
Read by machine on 9 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT07051486, who can take part
Where in China
- Fujian Cancer HospitalFuzhou, ChinaTaking people
- Shandong University Qilu HospitalJinan, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Jiangsu HengRui Medicine Co., Ltd.
- Trial code
- NCT07051486
- Record updated
- 17 November 2025
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: Voluntarily join this study, sign the informed consent, have good compliance, and can cooperate with follow-up; Female, aged 18-75 years old (including 18 and 75 years old, calculated on the day of signing the informed consent); Cervical cancer confirmed by tissue or cytological pathology; Expected survival ≥ 12 weeks; Normal function of important organs; Female subjects of fertility must have a negative serum HCG test within 7 days before the first dose of Investigational Medicinal Product (IMP), and must not be breastfeeding, and must agree to comply with contraceptive requirements from the signing of the informed consent until the last dose of the trial drug for 7 months.
Exclusion: Subjects with known lung damage caused by concurrent lung diseases; Subjects with arterial/venous thrombotic events within 1 month before enrollment; Subjects who had a serious infection within 1 month before enrollment; Subjects with other malignant tumors in the past or at the same time; Subjects with a history of interstitial pneumonia/interstitial lung disease or non-infectious pneumonia requiring steroid treatment; Subjects with autoimmune, connective tissue or inflammatory diseases involving the lungs; Subjects with active pulmonary tuberculosis; Subjects with poorly controlled or severe cardiovascular diseases; History of immunodeficiency, including positive HIV test; Subjects with known untreated or active central nervous system (CNS) tumor metastases; Subjects with clinically symptomatic, poorly controlled, or moderate or greater pleural effusion, pericardial effusion or peritoneal effusion.