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

Launched by SUZHOU SUNCADIA BIOPHARMACEUTICALS CO., LTD. · Feb 27, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called SHR-A1811 for women with recurrent or metastatic cervical cancer, which means the cancer has come back or spread to other parts of the body. The goal is to find out how safe the treatment is, how well it works, and how the body processes it. The trial is currently not recruiting participants, but it will eventually involve women aged 18 to 75 who are willing to participate and meet specific health criteria, such as having normal organ function and being able to comply with follow-up visits.

Eligible participants should also not have other active cancers, severe bone damage, or certain serious health conditions. If you join the study, you'll receive the new treatment and be monitored closely for any side effects and how well the treatment is working. It's important for women of childbearing age to agree to use birth control during the study and for some time after. Overall, this trial aims to explore a promising new option for women facing cervical cancer that has not responded to other treatments.

Gender

FEMALE

Eligibility criteria

• 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.