A Randomized, Open-Label, Controlled, Phase III Study of SHR-A1921 Versus Investigator's Choice of Chemotherapy in Patients With Platinum-Resistant Recurrent Epithelial Ovarian Cancer

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

This study is a randomized, open-label, controlled, phase III study to evaluate the efficacy and safety of SHR-A1921 versus investigator's choice of chemotherapy in patients with platinum-resistant recurrent epithelial ovarian cancer.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• Voluntary participation and written informed consent.

• 18 years and older, female.

• Pathologically diagnosed epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.

• Patients must have platinum-resistant disease

• Be able to provide fresh or archived tumour tissue.

• At least one measurable lesion according to RECIST v1.1.

• Eastern Cooperative Oncology Group (ECOG) score: 0-1.

• With a life expectancy ≥ 12 weeks.

• Adequate bone marrow reserve and organ function.

⁃ Contraception is required during the trial.

Locations
Other Locations
China
National Cancer Center/Tumor Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
RECRUITING
Beijing
Zhejiang Cancer Hospital
RECRUITING
Hangzhou
Contact Information
Primary
Shuni Wang
shuni.wang@hengrui.com
+86 021-61053363
Backup
Di Zong
di.zong@hengrui.com
+86 021-61053363
Time Frame
Start Date: 2024-05-10
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 440
Treatments
Experimental: Treatment group 1: SHR-A1921
Active_comparator: Treatment group 2: Investigator's choice of chemotherapy
Related Therapeutic Areas
Sponsors
Leads: Suzhou Suncadia Biopharmaceuticals Co., Ltd.

This content was sourced from clinicaltrials.gov