SHR-A1811 for HER2-positive recurrent or metastatic cervical cancer.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-arm, multicenter Phase II trial administering SHR-A1811 by injection to patients with HER2-expressing recurrent or metastatic cervical cancer who have failed prior systemic therapy. Eligible participants are adult women (18–75 years) with pathologically confirmed disease, expected survival of at least 12 weeks, and adequate organ function, and must meet contraception and pregnancy-testing requirements. Key exclusions include untreated or active central nervous system metastases, other concurrent malignancies, and clinically significant uncontrolled conditions such as symptomatic pleural effusions. The trial is sponsored by Jiangsu HengRui Medicine and is being conducted at sites in Fuzhou and Jinan, China.

Why it matters

Who can join: the full rules

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.

Where it's running

• Fujian Cancer Hospital
  Fuzhou, Fujian, China Recruiting
• Shandong University Qilu Hospital
  Jinan, Shandong, China Recruiting

Study contacts

• Study coordinator: Na An
• Email: na.an@hengrui.com
• Phone: +86-0518-82342973

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• SHR-A1811 combination regimen for recurrent or metastatic cervical cancer

  This trial tests a combination that includes the investigational agent SHR-A1811 with other cancer drugs to see if it helps people with recurrent or metastatic cervical cancer.

  Recruiting Phase 1/2 Suzhou Suncadia Biopharmaceuticals Co., Ltd. · Beijing, Beijing Municipality · NCT06859775

• Using immune cells to treat recurrent or metastatic cervical cancer

  This study is testing if a new immune cell treatment can work better than a standard chemotherapy drug for people with recurrent or metastatic cervical cancer.

  Recruiting at 31 sites Phase 2 Grit Biotechnology · Beijing, Beijing Municipality and 37 other locations · NCT06241781

• Low-dose Pembrolizumab with Chemotherapy for Advanced Cervical Cancer

  This study is testing if a low dose of pembrolizumab combined with chemotherapy can help women with advanced cervical cancer who can't have curative treatments feel better.

  Recruiting Phase 2 Instituto Nacional de Cancer, Brazil · Rio de Janeiro, Rio de Janeiro · NCT06670911

• GLS-010 plus platinum chemotherapy with or without bevacizumab as first-line treatment for persistent, recurrent, or metastatic cervical cancer

  This phase 3 trial tests whether adding GLS-010 to standard platinum-based chemotherapy, with or without bevacizumab, can improve outcomes as first-line treatment for persistent, recurrent, or metastatic cervical cancer.

  Recruiting Phase 3 Guangzhou Gloria Biosciences Co., Ltd. · Shanghai, Shanghai Municipality · NCT05798819

• Reirradiation and Total Ablative Strategies for Recurrent Gynecologic Cancer (REGYNERA-tion) Registry

  This registry tests how reirradiation and total ablative strategies are used in real-world care for adults with recurrent gynecologic cancers and tracks outcomes to see what happens after these treatments.

  Recruiting Affidea Nu-med Center of Oncological DIagnostics and Therapy · Zamość, Lublin Voivodeship · NCT07667192

• PD-1 versus PD-L1 immunotherapy combined with chemotherapy, with or without bevacizumab, for advanced cervical cancer.

  This trial tests whether giving PD-1 or PD-L1 immunotherapy alongside chemotherapy, with or without bevacizumab, helps adults with metastatic, persistent, or recurrent cervical cancer.

  Recruiting Phase 2/3 N.N. Alexandrov National Cancer Centre · Minsk, Lesnoy · NCT07472153

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.