A Single-Arm, Multicenter Phase II Clinical Trial of SHR-A1811 for Injection in Patients With HER2-Expressing Recurrent or Metastatic Cervical Cancer Progressing After Standard Treatment

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This study is a single-arm, multicenter Phase II clinical trial of SHR-A1811 for injection in patients with HER2-expressing recurrent or metastatic cervical cancer who have failed prior systemic therapy.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
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• Voluntarily join this study, sign the informed consent, have good compliance, and can cooperate with follow-up.

• Female, aged 18-75 years old (including 18 and 75 years old, calculated on the day of signing the informed consent).

• Cervical cancer confirmed by tissue or cytological pathology.

• Expected survival ≥ 12 weeks.

• Normal function of important organs.

• Female subjects of fertility must have a negative serum HCG test within 7 days before the first dose of Investigational Medicinal Product (IMP), and must not be breastfeeding, and must agree to comply with contraceptive requirements from the signing of the informed consent until the last dose of the trial drug for 7 months.

Locations
Other Locations
China
Fujian Cancer Hospital
RECRUITING
Fuzhou
Shandong University Qilu Hospital
RECRUITING
Jinan
Contact Information
Primary
Na An
na.an@hengrui.com
+86-0518-82342973
Time Frame
Start Date: 2025-10-11
Estimated Completion Date: 2026-08
Participants
Target number of participants: 60
Treatments
Experimental: SHR-A1811 Group
Related Therapeutic Areas
Sponsors
Leads: Jiangsu HengRui Medicine Co., Ltd.

This content was sourced from clinicaltrials.gov

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