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

Launched by JIANGSU HENGRUI MEDICINE CO., LTD. · Jun 26, 2025

Keywords

ClinConnect Summary

This clinical trial is testing a new treatment called SHR-A1811 for women with cervical cancer that has come back or spread to other parts of the body, and who have cancer cells that show a protein called HER2. The study is for patients who have already tried other treatments that didn’t work. The goal is to see how well SHR-A1811 works and how safe it is for these patients.

Women between 18 and 75 years old with confirmed cervical cancer may be eligible to join, as long as they have a good chance of living at least three more months and their important organs are working well. Participants need to be willing to follow the study rules and attend follow-up visits. Women who can become pregnant must have a negative pregnancy test before starting and agree to use birth control during the study and for several months afterward. The study is not yet enrolling patients, and women with certain health problems, like active brain cancer spread, other recent cancers, serious lung or heart issues, or infections like HIV, would not be able to join. If eligible, participants will receive SHR-A1811 and be carefully monitored to see how the treatment affects their cancer and overall health.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Voluntarily join this study, sign the informed consent, have good compliance, and can cooperate with follow-up.
• • 2. Female, aged 18-75 years old (including 18 and 75 years old, calculated on the day of signing the informed consent).
• • 3. Cervical cancer confirmed by tissue or cytological pathology.
• • 4. Expected survival ≥ 12 weeks.
• • 5. Normal function of important organs.
• • 6. 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 Criteria:
• • 1. Subjects with known untreated or active central nervous system (CNS) tumor metastases.
• • 2. Subjects with other malignant tumors in the past or at the same time.
• • 3. Subjects with clinically symptomatic, poorly controlled, or moderate or greater pleural effusion, pericardial effusion or peritoneal effusion.
• • 4. Subjects with a history of interstitial pneumonia/interstitial lung disease or non-infectious pneumonia requiring steroid treatment.
• • 5. Subjects with autoimmune, connective tissue or inflammatory diseases involving the lungs.
• • 6. Subjects with known lung damage caused by concurrent lung diseases.
• • 7. Subjects with active pulmonary tuberculosis.
• • 8. Subjects with poorly controlled or severe cardiovascular diseases.
• • 9. Subjects with arterial/venous thrombotic events within 1 month before enrollment.
• • 10. Subjects who had a serious infection within 1 month before enrollment.
• • 11. History of immunodeficiency, including positive HIV test.