SHR-A1921 for Injection in Patients With Platinum-Resistant Recurrent Epithelial Ovarian Cancer
NCT ID: NCT06394492
Last Updated: 2024-08-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
440 participants
INTERVENTIONAL
2024-05-10
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Treatment group 1: SHR-A1921
SHR-A1921
SHR-A1921 dose 1
Treatment group 2: Investigator's choice of chemotherapy
Doxorubicin
Doxorubicin dose 2
Paclitaxel
Paclitaxel dose 3
Topotecan
Topotecan dose 4
Interventions
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SHR-A1921
SHR-A1921 dose 1
Doxorubicin
Doxorubicin dose 2
Paclitaxel
Paclitaxel dose 3
Topotecan
Topotecan dose 4
Eligibility Criteria
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Inclusion Criteria
2. 18 years and older, female.
3. Pathologically diagnosed epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.
4. Patients must have platinum-resistant disease
5. Be able to provide fresh or archived tumour tissue.
6. At least one measurable lesion according to RECIST v1.1.
7. Eastern Cooperative Oncology Group (ECOG) score: 0-1.
8. With a life expectancy ≥ 12 weeks.
9. Adequate bone marrow reserve and organ function.
10. Contraception is required during the trial.
Exclusion Criteria
2. Previous or co-existing malignancies.
3. Current or History of ILD.
4. Clinical symptoms or diseases of the heart that are not well controlled.
5. Arterial/venous thrombosis events occurred before the first dose.
6. Grade ≥2 bleeding events of CTCAE occurred before the first dose.
7. Gastrointestinal perforation or fistula, urethral fistula, abdominal abscess occurred before the first dose.
8. Patients with intestinal obstruction or parenteral nutrition before the first dose.
9. Serious infection before the first dose.
10. Active hepatitis B or active hepatitis C.
11. Received systemic anticancer treatments 4 weeks prior to the initiation of the study treatment.
12. Treated with TOP1 inhibitors or ADCs with TOP1 inhibitors as payload.
13. Unresolved CTCAE ≥grade 2 toxicities from previous anticancer therapy.
14. History of severe hypersensitivity reactions to either the drug substances or inactive ingredients of SHR-A1921.
15. Other inappropriate situation considered by the investigator.
18 Years
FEMALE
No
Sponsors
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Suzhou Suncadia Biopharmaceuticals Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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National Cancer Center/Tumor Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Lingyin Wu, Doctor
Role: primary
Tao Zhu, Doctor
Role: primary
Other Identifiers
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SHR-A1921-303
Identifier Type: -
Identifier Source: org_study_id
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