Actively Recruiting
A Phase II Trial of SHR-A1811 in HER2-Expressing Recurrent/Metastatic Cervical Cancer
Led by Jiangsu HengRui Medicine Co., Ltd. · Updated on 2025-11-17
60
Participants Needed
2
Research Sites
42 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Phase II Trial of SHR-A1811 in HER2-Expressing Recurrent/Metastatic Cervical Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily agree to join the study, sign informed consent, and comply with follow-up
- Female, aged 18 to 75 years (inclusive) at consent signing
- Confirmed cervical cancer by tissue or cytology pathology
- Expected survival of at least 12 weeks
- Normal function of important organs
- Negative serum HCG test within 7 days before first dose if of childbearing potential
- Not breastfeeding and agree to use contraception from consent until 7 months after last dose
You will not qualify if you...
- Known untreated or active central nervous system tumor metastases
- Other malignant tumors in the past or present
- Clinically symptomatic or moderate/severe pleural, pericardial, or peritoneal effusion
- History of interstitial pneumonia or lung disease requiring steroid treatment
- Autoimmune, connective tissue, or inflammatory lung diseases
- Known lung damage from other lung diseases
- Active pulmonary tuberculosis
- Poorly controlled or severe cardiovascular diseases
- Arterial or venous blood clots within 1 month before enrollment
- Serious infection within 1 month before enrollment
- History of immunodeficiency, including positive HIV test
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Fujian Cancer Hospital
Fuzhou, Fujian, China, 350011
Actively Recruiting
2
Shandong University Qilu Hospital
Jinan, Shandong, China, 250063
Actively Recruiting
Research Team
N
Na An
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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