Actively Recruiting
A Study of SHR-A1811 in Subjects With Gynaecologic Oncology
Led by Jiangsu HengRui Medicine Co., Ltd. · Updated on 2023-08-22
225
Participants Needed
1
Research Sites
153 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is an open-label, two-part study to evaluate the safety and efficacy of SHR-A1811 for injection in subjects with a gynaecological malignancies.
CONDITIONS
Official Title
A Study of SHR-A1811 in Subjects With Gynaecologic Oncology
Who Can Participate
Eligibility Criteria
You may qualify if you...
- The subjects voluntarily joined the study and signed the informed consent form.
- Measurable disease as defined by RECIST v1.1.
- Eastern Cancer Cooperative Group (ECOG) performance status of 0 or 1.
- Life expectancy of at least 12 weeks.
- Subjects with advanced cervical cancer, recurrent ovarian cancer, or endometrial cancer.
You will not qualify if you...
- Symptomatic, untreated, or active central nervous system metastases.
- Previous treatment with antibody-drug conjugates containing topoisomerase I inhibitors such as Enhertu (DS-8201a) or U3-1402.
- Uncontrolled or severe cardiovascular disease.
- Active autoimmune disease or history of autoimmune disease.
- Active hepatitis B or hepatitis C infection.
- Severe infections within 28 days before starting study treatment.
- Active tuberculosis within one year before starting study treatment.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Qilu Hospital of Shandong University
Jinan, Shandong, China, 250012
Actively Recruiting
Research Team
B
Bo Li, Ph.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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