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Spots Global Cancer Trial Database for RC88 in Platinum-Resistant Recurrent Epithelial Ovarian Cancer, Fallopian Tube Cancer, and Primary Peritoneal Cancer

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Trial Identification

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

Interventions

RC88

Study Description

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).

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

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

Contact Details

Name: Jianmin Fang, Ph.D

Affiliation: RemeGen Co., Ltd.

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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