Open-label, Multicenter Phase Ib/II Clinical Study of Injectable SHR-A1811 in Combination Regimens for the Treatment of Recurrent or Metastatic Cervical Cancer

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
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• 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.

Locations
Other Locations
China
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
RECRUITING
Beijing
Contact Information
Primary
Na An
na.an@hengrui.com
+86-0518-82342973
Time Frame
Start Date: 2025-04-25
Estimated Completion Date: 2027-01
Participants
Target number of participants: 100
Treatments
Experimental: Treatment cohort 1
Experimental: Treatment cohort 2
Experimental: Treatment cohort 3
Related Therapeutic Areas
Sponsors
Leads: Suzhou Suncadia Biopharmaceuticals Co., Ltd.

This content was sourced from clinicaltrials.gov

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