RecruitingRecruiting
A Study of SHR-A1811 in Subjects With Ovarian Cancer
NCT06828354 · Jiangsu HengRui Medicine Co., Ltd.
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
An Open-label, Randomized, Multicenter Phase III Clinical Trial of SHR-A1811 Versus Investigator-selected Chemotherapy for Platinum-resistant Relapsed Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
About this study
This is an open-label study to evaluate the safety and efficacy of SHR-A1811 for injection in subjects with ovarian cancer.
Eligibility criteria
Inclusion Criteria:
1. The subjects voluntarily joined the study and signed the Informed consent forms (ICF).
2. Measurable disease, as defined by RECIST v1.1.
3. The Eastern Cancer Cooperative Group (ECOG) performance status of 0 or 1.
4. Life expectancy ≥ 12 weeks.
Exclusion Criteria:
1. Symptomatic, untreated or active central nervous system metastases.
2. Have uncontrolled or severe cardiovascular disease.
3. With any active autoimmune disease or history of autoimmune disease.
4. Patients with active hepatitis B or hepatitis C.
5. Severe infections prior to initiation of study treatment.
6. Patients with active tuberculosis.
Study design
Enrollment target: 300 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-03-13
Estimated completion: 2027-12
Last updated: 2026-04-20
Interventions
Drug: SHR-A1811Drug: Paclitaxel InjectionDrug: Doxorubicin Hydrochloride Liposome InjectionDrug: Gemcitabine Hydrochloride for InjectionDrug: Topotecan Hydrochloride for Injection
Primary outcomes
- • Progression free survival (PFS) (From day 1 to 10 months.)
Sponsor
Jiangsu HengRui Medicine Co., Ltd. · industry
Contacts & investigators
ContactYuanchao Wang · contact · yuanchao.wang@hengrui.com · 0518-82342973
All locations (2)
Tongji Hospital Affiliated to Tongji Medical College, Huazhong University of Science and TechnologyRecruiting
Wuhan, Hubei, China
Qilu Hospital of Shandong UniversityRecruiting
Jinan, Shandong, China