A Study of SHR-A1811 in Subjects With Ovarian Cancer
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
1 other identifier
interventional
300
1 country
2
Brief Summary
This is an open-label study to evaluate the safety and efficacy of SHR-A1811 for injection in subjects with ovarian cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 ovarian-cancer
Started Mar 2025
Shorter than P25 for phase_3 ovarian-cancer
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 10, 2025
CompletedFirst Posted
Study publicly available on registry
February 14, 2025
CompletedStudy Start
First participant enrolled
March 13, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2027
April 20, 2026
April 1, 2026
2.1 years
February 10, 2025
April 15, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Progression free survival (PFS)
From day 1 to 10 months.
Secondary Outcomes (6)
Objective response rate (ORR)
From day 1 to 12 months.
Disease control rate (DCR)
From day 1 to 12 months.
Duration of response (DOR)
From day 1 to 12 months.
Overall survival (OS)
From day 1 to 12 months.
Response rate (RR)
From day 1 to 12 months.
- +1 more secondary outcomes
Study Arms (2)
SHR-A1811 group
EXPERIMENTALChemotherapy group
ACTIVE COMPARATORInterventions
Doxorubicin Hydrochloride Liposome Injection.
Gemcitabine Hydrochloride for Injection.
Eligibility Criteria
You may qualify if:
- The subjects voluntarily joined the study and signed the Informed consent forms (ICF).
- Measurable disease, as defined by RECIST v1.1.
- The Eastern Cancer Cooperative Group (ECOG) performance status of 0 or 1.
- Life expectancy ≥ 12 weeks.
You may not qualify if:
- Symptomatic, untreated or active central nervous system metastases.
- Have uncontrolled or severe cardiovascular disease.
- With any active autoimmune disease or history of autoimmune disease.
- Patients with active hepatitis B or hepatitis C.
- Severe infections prior to initiation of study treatment.
- Patients with active tuberculosis.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Tongji Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030, China
Qilu Hospital of Shandong University
Jinan, Shandong, 250012, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 10, 2025
First Posted
February 14, 2025
Study Start
March 13, 2025
Primary Completion (Estimated)
May 1, 2027
Study Completion (Estimated)
December 1, 2027
Last Updated
April 20, 2026
Record last verified: 2026-04