Actively Recruiting
Open, Multicenter Phase II Clinical Study of SHR-A1811 for Injection in the Treatment of Gynaecological Malignancies
Led by Jiangsu HengRui Medicine Co., Ltd. · Updated on 2023-08-22
225
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of SHR-A1811 injection in adults with gynecological cancers, including advanced cervical, recurrent ovarian, and endometrial cancers. This open-label Phase II study is conducted by Jiangsu HengRui Medicine Co., Ltd. and aims to measure how well this treatment works and its safety profile in this patient group. Participants will receive SHR-A1811 as the study treatment. The trial is designed in two parts and does not involve placebo or blinding. The primary measure is the objective response rate over 12 months, alongside secondary measures such as progression-free survival, disease control rate, duration of response, overall survival, and monitoring of adverse events from the first day of treatment until 90 days after the last dose. During the study, participants will be monitored regularly to assess treatment response and safety. Evaluations include assessments of cancer progression and side effects. The total involvement includes follow-up for at least 12 months to track key outcomes. The study enrolls females aged 18 to 75 with measurable disease and a good performance status, who have a life expectancy of at least 12 weeks.
CONDITIONS
Brief 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.
- Prior 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 months
Participants receive the study drug SHR-A1811 as treatment for gynaecological malignancies.
Visit schedule according to treatment cycles
Duration - Up to 90 days
Participants are monitored for safety and outcomes for up to 90 days after the last dose of study treatment.
Multiple follow-up visits
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.
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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