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A I/II Phase Clinical Study to Evaluate the Safety and Efficacy of RC278 in the Treatment of Solid Tumors
Sponsor: RemeGen Co., Ltd.
Summary
The primary objective is to evaluate the safety and tolerability of RC278; determine the maximum tolerated dose (MTD) and/or maximum administered dose (MAD) of RC278; and determine the recommended phase 2 dose (RP2D), and assess the efficacy of RC278 at the RP2D dose;
Official title: A Multicenter Phase I/II Clinical Study to Evaluate the Safety and Efficacy of RC278 for Injection in the Treatment of Locally Advanced Unresectable or Metastatic Malignant Solid Tumor
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
312
Start Date
2025-08-11
Completion Date
2030-05-31
Last Updated
2025-11-26
Healthy Volunteers
No
Conditions
Interventions
RC278
Intravenous (IV) administration of RC278 Q3W. Patients will continue treatment until unacceptable toxicities, disease progression, or any criterion for withdrawl from the study.
Locations (39)
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Fujian Cancer Hospital
Fuzhou, Fujian, China
Fujian Cancer Hospital
Fuzhou, Fujian, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
The Second Affiliated Hospital of Guilin Medical University
Guilin, Guangxi, China
Guangxi Medical University Cancer Hospital & Guangxi Cancer Institute
Nanning, Guangxi, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
Anyang Cancer Hospital
Luoyan, Henan, China
The First Affiliated Hospital of Henan University of Science &Technology
Luoyang, Henan, China
Nanyang Second General Hospital
Nanyang, Henan, China
The First Affiliated Hospital of Xinxiang Medical University
Xinxiang, Henan, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, China
Wuhan, Hu'Nan, China
Hubei Cancer Hospital
Wuhan, Hubei, China
Tongji Hospital, Tongji Medical College of HUST, China
Wuhan, Hubei, China
Hunan Cancer Hospital
Changsha, Hunan, China
Hunan Cancer Hospital
Changsha, Hunan, China
Hunan Cancer Hospital
Changsha, Hunan, China
Hunan Cancer Hospital
Changsha, Hunan, China
Jiangsu Province Hospital
Nanjing, Jiangsu, China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China
Xuzhou Central Hospital
Xuzhou, Jiangsu, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Liaoning Cancer Hospital & Institute
Shenyang, Liaoning, China
The first Hospital of China Medical University
Shenyang, Liaoning, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China
West China Hospital of Sichuan University
Chengdu, Sichuan, China
Yunnan Tumor Hospital
Kunming, Yunnan, China
Sir Run Run Shaw Hospital, affiliated with Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Taizhou Hospital of Zhejiang Province
Taizhou, Zhejiang, China
Sun Yat-sen University Cancer Center
Guangzhou, China
The First Affiliated Hospital, Zhejiang University School Of Medicine
Hangzhou, China
Cancer Hospital of Shandong First Medical University
Jinan, China
Jinan Central Hospital
Jinan, China
Shanxi Cancer Hospital
Taiyuan, China
Henan Cancer Hospital
Zhengzhou, China