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Brief Title: RC88 in Platinum-Resistant Recurrent Epithelial Ovarian Cancer, Fallopian Tube Cancer, and Primary Peritoneal Cancer
Official Title: A Multicenter, Single-arm, Phase 2 Study to Evaluate the Efficacy, Safety and Pharmacokenetics of RC88 Monotherapy in Platinum-resistant Reccurent Epithelial Ovarian, Fallopian Tube and Primary Peritoneal Cancer
Study ID: NCT06173037
Brief Summary: This study is designed to evaluate the efficacy, safety, and pharmacokinetics of RC88 monotherapy in subjects with Platinum-Resistant Recurrent Epithelial Ovarian, Fallopian Tube and Primary Peritoneal Cancer (PROC).
Detailed Description: This study is designed to evaluate the efficacy, safety, and pharmacokinetics of RC88 monotherapy in subjects with Platinum-Resistant Recurrent Epithelial Ovarian, Fallopian Tube and Primary Peritoneal Cancer (PROC). Approximately 88 eligible patients will be enrolled,and all patients will receive single-agent RC88 at 2.0 mg/kg administered on Day 1 of every 3-week cycle (Q3W). Patients will continue to receive RC88 until disease progression, unacceptable toxicity, withdrawal of consent, death, or until the Sponsor terminates the study (whichever comes first). Tumor assessments, including radiological assessments by CT/MRI scans will be performed at Screening and subsequently every 6 weeks (± 1 week) from Cycle 1 Day 1 (C1D1) for the first 48 weeks then every 12 weeks (± 1 week) until disease progression, death, the start of new anticancer therapy, or patient's withdrawal of consent (whichever occurs first). All patients who discontinue RC88 will be followed for survival every 3 months (± 2 weeks) until death, lost to follow-up, withdrawal of consent for survival follow-up, or end of study (whichever comes first).
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
The first affiliated hospital of bengbu medical college, Bengbu, Anhui, China
Anhui Provincial Hospital, Hefei, Anhui, China
Cancer Hospital Chinese Academy of Medical Sciences, Beijing, Beijing, China
Peking University People's Hospital, Beijing, Beijing, China
Harbin Medical University Cancer Hospital, Harbin, Heilongjiang, China
The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, China
Zhongnan Hospital of Wuhan University, Wuhan, Hubei, China
Hubei Cancer Hospital, Wuhan, Hubei, China
Xiangyang Central Hospital, Xiangyang, Hubei, China
Hunan Cancer Hospital, Changsha, Hunan, China
Nanjing Drum Tower Hospital, Nanjing, Jiangsu, China
Jilin Cancer Hospital, Changchun, Jilin, China
Qilu Hospital of Shandong University, JiNan, Shandong, China
Shandong Cancer Hospital & Institute, JiNan, Shandong, China
Qilu Hospital of Shandong University, Jinan, Shangdong, China
Obstetrics & Gynecology Hospital of Fudan University, Shanghai, Shanghai, China
Second hospital of Shanxi Medical University, Taiyuan, Shanxi, China
Tianjin Medical University Cancer Institute & Hospital, Tianjin, Tianjin, China
Yunnan Cancer Hospital, Kunming, Yunnan, China
The Second Affiliated Hospital Zhejiang University School of Medicine, Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital, Hangzhou, Zhejiang, China
Zhejiang Provincial People's Hospital, Hangzhou, Zhejiang, China
Name: Jianmin Fang, Ph.D
Affiliation: RemeGen Co., Ltd.
Role: STUDY_DIRECTOR