A Multicenter, Single-arm, Phase 2 Study to Evaluate the Efficacy, Safety and Pharmacokinetics of RC88 Monotherapy in Platinum-resistant Recurrent Epithelial Ovarian, Fallopian Tube and Primary Peritoneal Cancer
The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of RC88 monotherapy in subjects with Platinum-Resistant Recurrent Epithelial Ovarian, Fallopian Tube and Primary Peritoneal Cancer.
• Agree to participate in the study and sign an Informed Consent Form;
• Female subjects aged 18 years or older at the time of signing the Informed Consent Form;
• Histology confirmed high grade serous ovarian, fallopian tube or primary peritoneal cancer;
• Must be newly developed platinum-resistant (Must not have received systemic therapy after developing platinum resistance status);
• Received at least 3 prior lines of systemic therapies;
• Imaging evidence of disease progression during or at the end of last-line therapy;
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1;
• Life expectancy of at least 12 weeks;
• Subjects are willing to provide archival tumor tissue samples or accept a low-risk routine medical procedure to collect the fresh biopsy sample for immunohistochemical (IHC) MSLN testing;
⁃ Measurable lesion according to RECIST v1.1;
⁃ The interval between previous focal radiotherapy and the first dose should be at least 2 weeks;
⁃ Have laboratory tests that meet the relevant requirements to demonstrate adequate organ function;
⁃ Subjects of childbearing potential are required to use effective contraception from the time of informed consent and continuing through 6 months after the final dose of study intervention; Fertile subjects included those who were not menopausal or had been menopausal for less than 2 years and had not undergone bilateral adnexectomy or hysterectomy;Subjects of childbearing potential must have a negative pregnancy test within 7 days prior to the first dose of study intervention.