SHR-A1811 Combination Regimen for the Treatment of Recurrent or Metastatic Cervical Cancer

Recruiting now · Phase 1/Phase 2

Conditions studied: Recurrent or Metastatic Cervical Cancer

In brief

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.

Key facts

Study ID

NCT06859775

Run by

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

People needed

100

Starts

2025-04-25

Expected to finish

2027-01-01

Last updated by the study team

2025-06-06

Who can join

Age: 18 and older, up to 75. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Peking Union Medical College Hospital, Chinese Academy of Medical Sciences — Beijing, Beijing Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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