A Phase II Trial of SHR-A1811 in HER2-Expressing Recurrent/Metastatic Cervical Cancer
NCT ID: NCT07051486
Last Updated: 2025-11-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
60 participants
INTERVENTIONAL
2025-10-11
2026-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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SHR-A1811 Group
SHR-A1811 Injection
SHR-A1811 for injection.
Interventions
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SHR-A1811 Injection
SHR-A1811 for injection.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
75 Years
FEMALE
No
Sponsors
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Jiangsu HengRui Medicine Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Fujian Cancer Hospital
Fuzhou, Fujian, China
Shandong University Qilu Hospital
Jinan, Shandong, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SHR-A1811-218
Identifier Type: -
Identifier Source: org_study_id
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