Actively Recruiting
SHR-A1921 for Injection in Patients With Platinum-Resistant Recurrent Epithelial Ovarian Cancer
Led by Suzhou Suncadia Biopharmaceuticals Co., Ltd. · Updated on 2024-08-09
440
Participants Needed
2
Research Sites
137 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
SHR-A1921 for Injection in Patients With Platinum-Resistant Recurrent Epithelial Ovarian Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntary participation and written informed consent
- Female, aged 18 years or older
- Diagnosed with epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer
- Have platinum-resistant disease
- Able to provide fresh or archived tumor tissue
- Have at least one measurable lesion according to RECIST v1.1
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Life expectancy of at least 12 weeks
- Adequate bone marrow reserve and organ function
- Use contraception during the trial
You will not qualify if you...
- Uncontrolled pleural, pericardial, or abdominal effusion with clinical symptoms
- Previous or co-existing malignancies
- Current or history of interstitial lung disease (ILD)
- Uncontrolled heart diseases or symptoms
- Arterial or venous thrombosis before the first dose
- Grade 2 or higher bleeding events before the first dose
- Gastrointestinal perforation, fistula, or abdominal abscess before the first dose
- Intestinal obstruction or need for parenteral nutrition before the first dose
- Serious infection before the first dose
- Active hepatitis B or C infection
- Received systemic anticancer treatments within 4 weeks before starting study treatment
- Previous treatment with TOP1 inhibitors or antibody-drug conjugates with TOP1 inhibitors
- Unresolved grade 2 or higher toxicities from prior anticancer therapy
- History of severe allergic reactions to SHR-A1921 or its ingredients
- Other conditions deemed inappropriate by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
National Cancer Center/Tumor Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, China, 100021
Actively Recruiting
2
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China, 310022
Actively Recruiting
Research Team
S
Shuni Wang
CONTACT
D
Di Zong
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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