SHR-A1811 Combination Regimen for the Treatment of Recurrent or Metastatic Cervical Cancer
Open-label, Multicenter Phase Ib/II Clinical Study of Injectable SHR-A1811 in Combination Regimens for the Treatment of Recurrent or Metastatic Cervical Cancer
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
100 participants
Apr 25, 2025
INTERVENTIONAL
Conditions
Summary
This study is a multicentre, open-label, dose-finding/efficacy-expanding phase Ib/II clinical trial to evaluate the tolerability, safety, pharmacokinetic profile and immunogenicity of SHR-A1811 combination regimen in the treatment of recurrent or metastatic cervical cancer and to preliminarily evaluate the efficacy of SHR-A1811 combination regimen for recurrent or metastatic cervical cancer.
Eligibility
Inclusion Criteria6
- Subjects must voluntarily join this study, sign the informed consent form, have good compliance and be able to cooperate with the follow-up.
- Female, aged 18-75 years old.
- Expected survival ≥ 12 weeks.
- Normal function of vital organs.
- 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.
- 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 Criteria10
- Previous or concomitant other malignancies.
- Severe bone damage caused by bone metastasis from tumours.
- Presence of active autoimmune disease or history of autoimmune disease with possible recurrence.
- Those with active tuberculosis.
- Concomitant poorly controlled or severe cardiovascular disease.
- Occurrence of arteriovenous thrombotic events within 6 months prior to the first dose.
- Presence of gastrointestinal obstruction or presence of symptoms and signs of gastrointestinal obstruction within 6 months prior to the first dose.
- Subjects who have had a serious infection within 1 month before the first dose.
- Subjects who have a history of immunodeficiency.
- 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.
Interventions
Bevacizumab injection.
SHR-8068 injection.
Cisplatin injection.
Carboplatin injection.
SHR-A1811 injection.
Adebelimab injection.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06859775