SHR-A1921 for Injection in Patients With Platinum-Resistant Recurrent Epithelial Ovarian Cancer
A Randomized, Open-Label, Controlled, Phase III Study of SHR-A1921 Versus Investigator's Choice of Chemotherapy in Patients With Platinum-Resistant Recurrent Epithelial Ovarian Cancer
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
440 participants
May 10, 2024
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria10
- 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.
Exclusion Criteria15
- 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.
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Interventions
SHR-A1921 dose 1
Doxorubicin dose 2
Paclitaxel dose 3
Topotecan dose 4
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06394492