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Recruiting Phase 2

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

NCT07051486 · tracked via the Priya Life Science China tracker
Phase
Phase 2
Started
2025-10-11
Last updated
2025-11-17

Condition(s) studied

Recurrent or Metastatic Cervical Cancer

Investigational drug(s) / intervention(s)

SHR-A1811 Injection →

SHR-A1811 Injection: SHR-A1811 for injection.

Study 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
FEMALE
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Objective response rate (ORR) assessed by Independent Review Committee (IRC) — Up to 2 years.

Trial sites (2)

FacilityCityRegionStatus
Fujian Cancer Hospital Fuzhou Fujian Recruiting
Shandong University Qilu Hospital Jinan Shandong Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07051486 on ClinicalTrials.gov ↗ ← All trials in China