Phase
Condition
Ovarian Cancer
Ovarian Cysts
Pelvic Cancer
Treatment
Topotecan
Doxorubicin
Paclitaxel
Clinical Study ID
Ages > 18 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Voluntary participation and written informed consent.
18 years and older, female.
Pathologically diagnosed epithelial ovarian cancer, primary peritoneal cancer, orfallopian 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
Exclusion Criteria:
Uncontrolled pleural effusion, pericardial effusion, or abdominal effusion withclinical 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 abscessoccurred 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 studytreatment.
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 orinactive ingredients of SHR-A1921.
Other inappropriate situation considered by the investigator.
Study Design
Connect with a study center
National Cancer Center/Tumor Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing 100021
ChinaActive - Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang 310022
ChinaActive - Recruiting
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