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RECRUITING
NCT07105215
PHASE1/PHASE2

A I/II Phase Clinical Study to Evaluate the Safety and Efficacy of RC278 in the Treatment of Solid Tumors

Sponsor: RemeGen Co., Ltd.

View on ClinicalTrials.gov

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

DRUG

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