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

Status: Recruiting
Location: See all (30) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Beijing Cancer Hospital
RECRUITING
Beijing
Cancer Hospital Chinese Academy of Medical Sciences
RECRUITING
Beijing
Peking University People's Hospital
RECRUITING
Beijing
Jilin Cancer Hospital
RECRUITING
Changchun
The First Hospital of Jilin University
RECRUITING
Changchun
Hunan Cancer Hospital
RECRUITING
Changsha
The West China Second University Hospital of Sichuan University
RECRUITING
Chengdu
Chongqing University Cancer Hospital
RECRUITING
Chongqing
Fujian Cancer Hospital
RECRUITING
Fuzhou
Sun Yat-sen University Cancer Center
RECRUITING
Guangzhou
The Second Affiliated Hospital Zhejiang University School of Medicine
RECRUITING
Hangzhou
Zhejiang Cancer Hospital
RECRUITING
Hangzhou
Zhejiang Provincial People's Hospital
RECRUITING
Hangzhou
Harbin Medical University Cancer Hospital
RECRUITING
Harbin
Anhui Provincial Hospital
RECRUITING
Hefei
Qilu Hospital of Shandong University
RECRUITING
Jinan
Shandong Cancer Hospital, Shandong Cancer Institute
RECRUITING
Jinan
Yunnan Cancer Hospital
RECRUITING
Kunming
Nanjing Drum Tower Hospital
RECRUITING
Nanjing
Zhongda Hospital Southeast University
RECRUITING
Nanjing
Qingdao Central Hospital
RECRUITING
Qingdao
Obstetrics & Gynecology Hospital of Fudan University
RECRUITING
Shanghai
Second hospital of Shanxi Medical University
RECRUITING
Taiyuan
Tianjin Medical University Cancer Institute & Hospital
RECRUITING
Tianjin
Hubei Cancer Hospital
RECRUITING
Wuhan
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
RECRUITING
Wuhan
Zhongnan Hospital of Wuhan University
RECRUITING
Wuhan
Xiangyang Central Hospital
RECRUITING
Xiangyang
Xingtai People's Hospital
RECRUITING
Xingtai
The First Affiliated Hospital of Zhengzhou University
RECRUITING
Zhengzhou
Contact Information
Primary
Heping Liu
heping.liu@remegen.com
+8610-65384976
Time Frame
Start Date: 2024-01-19
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 88
Treatments
Experimental: RC88 for Injection
Participants will receive RC88 2.0 mg/kg every 3 weeks (Q3W)
Related Therapeutic Areas
Sponsors
Leads: RemeGen Co., Ltd.

This content was sourced from clinicaltrials.gov