Recurrent or Metastatic Cervical Cancer
Conditions
Brief 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.
Interventions
DRUGSHR-A1811
SHR-A1811 injection.
Adebelimab injection.
DRUGBevacizumab injection
Bevacizumab injection.
DRUGSHR-8068
SHR-8068 injection.
DRUGCisplatin injection
Cisplatin injection.
DRUGCarboplatin injection
Carboplatin injection.
Sponsors
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Subjects must voluntarily join this study, sign the informed consent form, have good compliance and be able to cooperate with the follow-up. 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
1. Previous or concomitant other malignancies. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Grade≥3 drug-related adverse events (TRAEs). | Up to 3 years. |
| Grade≥3 drug-related serious adverse events (TRAEs). | Up to 3 years. |
| Objective response rate (ORR). | Up to 3 years. |
Secondary
| Measure | Time frame |
|---|---|
| Duration of response (DOR). | Up to 3 years. |
| Overall survival (OS). | Up to 3 years. |
| Disease control rate (DCR). | Up to 3 years. |
| Progression-free survival (PFS). | Up to 3 years. |
Countries
China
Contacts
Primary ContactNa An
Outcome results
None listed