SHR-A1921 for Injection in Patients With Platinum-Resistant Recurrent Epithelial Ovarian Cancer

Recruiting now · Phase 3

Conditions studied: Ovarian Cancer

In brief

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.

Key facts

Study ID

NCT06394492

Run by

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

People needed

440

Starts

2024-05-10

Expected to finish

2026-12-31

Last updated by the study team

2024-08-09

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Voluntary participation and written informed consent.
• 18 years and older, female.
• Pathologically diagnosed epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.
• Patients must have platinum-resistant disease
• Be able to provide fresh or archived tumour tissue.
• At least one measurable lesion according to RECIST v1.1.
• Eastern Cooperative Oncology Group (ECOG) score: 0-1.
• With a life expectancy ≥ 12 weeks.
• Adequate bone marrow reserve and organ function.
• Contraception is required during the trial.

You may not qualify if…

• Uncontrolled pleural effusion, pericardial effusion, or abdominal effusion with clinical symptoms.
• Previous or co-existing malignancies.
• Current or History of ILD.
• Clinical symptoms or diseases of the heart that are not well controlled.
• Arterial/venous thrombosis events occurred before the first dose.
• Grade ≥2 bleeding events of CTCAE occurred before the first dose.
• Gastrointestinal perforation or fistula, urethral fistula, abdominal abscess occurred before the first dose.
• Patients with intestinal obstruction or parenteral nutrition before the first dose.
• Serious infection before the first dose.
• Active hepatitis B or active hepatitis C.
• Received systemic anticancer treatments 4 weeks prior to the initiation of the study treatment.
• Treated with TOP1 inhibitors or ADCs with TOP1 inhibitors as payload.
• Unresolved CTCAE ≥grade 2 toxicities from previous anticancer therapy.
• History of severe hypersensitivity reactions to either the drug substances or inactive ingredients of SHR-A1921.
• Other inappropriate situation considered by the investigator.

Where it is running

• National Cancer Center/Tumor Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College — Beijing, Beijing Municipality, China (enrolling)
• Zhejiang Cancer Hospital — Hangzhou, Zhejiang, China (enrolling)

Full record on ClinicalTrials.gov

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