SHR-A1811 Combination Regimen for the Treatment of Recurrent or Metastatic Cervical Cancer
NCT ID: NCT06859775
Last Updated: 2025-06-06
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
PHASE1/PHASE2
100 participants
INTERVENTIONAL
2025-04-25
2027-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment cohort 1
SHR-A1811
SHR-A1811 injection.
Adebelimab injection
Adebelimab injection.
Bevacizumab injection
Bevacizumab injection.
Treatment cohort 2
SHR-A1811
SHR-A1811 injection.
Adebelimab injection
Adebelimab injection.
Bevacizumab injection
Bevacizumab injection.
SHR-8068
SHR-8068 injection.
Treatment cohort 3
SHR-A1811
SHR-A1811 injection.
Adebelimab injection
Adebelimab injection.
Bevacizumab injection
Bevacizumab injection.
SHR-8068
SHR-8068 injection.
Cisplatin injection
Cisplatin injection.
Carboplatin injection
Carboplatin injection.
Interventions
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SHR-A1811
SHR-A1811 injection.
Adebelimab injection
Adebelimab injection.
Bevacizumab injection
Bevacizumab injection.
SHR-8068
SHR-8068 injection.
Cisplatin injection
Cisplatin injection.
Carboplatin injection
Carboplatin injection.
Eligibility Criteria
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Inclusion Criteria
2. Female, aged 18-75 years old.
3. Expected survival ≥ 12 weeks.
4. Normal function of vital organs.
5. Female subjects of childbearing potential must have a negative serum HCG test within 7 days prior to the first dose and must be non-lactating.
6. Female subjects must agree to comply with contraceptive requirements from signing the informed consent form to 7 months after the last dose of the investigational drug.
Exclusion Criteria
2. Severe bone damage caused by bone metastasis from tumours.
3. Presence of active autoimmune disease or history of autoimmune disease with possible recurrence.
4. Those with active tuberculosis.
5. Concomitant poorly controlled or severe cardiovascular disease.
6. Occurrence of arteriovenous thrombotic events within 6 months prior to the first dose.
7. Presence of gastrointestinal obstruction or presence of symptoms and signs of gastrointestinal obstruction within 6 months prior to the first dose.
8. Subjects who have had a serious infection within 1 month before the first dose.
9. Subjects who have a history of immunodeficiency.
10. As judged by the investigator, there are other factors that may affect the results of the study or cause the study to be forced to terminate halfway.
18 Years
75 Years
FEMALE
No
Sponsors
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Suzhou Suncadia Biopharmaceuticals Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 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-A1811-216-CC
Identifier Type: -
Identifier Source: org_study_id
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