SHR-A1811 for HER2-positive recurrent or 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

This trial tests SHR-A1811 in people with HER2-expressing recurrent or metastatic cervical cancer whose disease did not respond to prior systemic therapy.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 75 Years
• Sex: Female
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. (Industry-sponsored)
• Locations: 2 sites (Fuzhou, Fujian and 1 other locations)
• Trial ID: NCT07051486 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Women aged 18–75 with pathologically confirmed recurrent or metastatic HER2-expressing cervical cancer who have progressed after prior systemic therapy, have adequate organ function, and meet the trial's contraception and survival requirements.

Not a fit: Patients with untreated or active brain metastases, other concurrent cancers, poor organ function, or who are pregnant or breastfeeding are unlikely to benefit or be eligible for this trial.

Why it matters

Potential benefit: If SHR-A1811 is effective, it could offer a new targeted treatment option for patients with HER2-expressing recurrent or metastatic cervical cancer and potentially improve disease control.

How similar studies have performed: HER2-targeted therapies have shown benefit in other HER2-positive cancers, but SHR-A1811's effectiveness in cervical cancer remains largely unproven with limited published data.

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.

Where this trial is running

Fuzhou, Fujian and 1 other locations

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

Study contacts

• Study coordinator: Na An

Conditions Recurrent or Metastatic Cervical Cancer