Clinical Research Directory
Browse clinical research sites, groups, and studies.
A Multicenter, Phase 3 Study of IBI343 Monotherapy Versus Treatment of Investigator's Choice in Subjects With Previously Treated, Claudin (CLDN) 18.2-positive, HER2-negative, Gastric or Gastroesophageal Junction Adenocarcinoma (G-HOPE-001)
Sponsor: Innovent Biologics (Suzhou) Co. Ltd.
Summary
This is a Multicenter, Randomized, Open-label, Phase 3 Study of IBI343 Monotherapy Versus Treatment of Investigator's Choice in Subjects with Previously Treated Claudin (CLDN) 18.2-positive, HER2-negative, Locally Advanced, Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma to compare the progression free survival (PFS) and overall survival (OS)
Official title: A Multicenter, Randomized, Open-label, Phase 3 Study of IBI343 Monotherapy Versus Treatment of Investigator's Choice in Subjects With Previously Treated, Claudin (CLDN) 18.2-positive, HER2-negative, Locally Advanced, Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
464
Start Date
2024-06-30
Completion Date
2027-12-31
Last Updated
2026-05-13
Healthy Volunteers
No
Interventions
Irinotecan OR Paclitaxel or Trifluridine/tipiracil（ FTD/TPI）
Drugs: Irinotecan Subjects in the control arm will receive irnotecan 150mg/m2 IV D1, D15, Q4W in 4-weeks cycles. Drugs: Paclitaxel Subjects in the control arm will receive paclitaxel 80mg/m2 IV D1, D8, D15, Q4W in 4-week cycles, Drugs:FTD/TPI Subjects in the control arm will receive FTD/TPI 35 mg/m2 up to a maximum of 80 mg orally twice a day on Days 1 to 5 and Days 8 to 12, Q4W (applicable in US/EU/Japan and other regions where FTD/TPI is approved for GC treatment).
IBI343
Subjects in the experimental arm will receive IBI343 6mg/kg intravenous infusion (IV) D1, Q3W in 3-week cycles .
Locations (95)
The First Affiliated Hospital of Bengbu Medical University
Bengbu, Anhui, China
Anhui Provincial Hospital
Hefei, Anhui, China
The First Affiliated Hospital of USTC /Anhui Provincial Hospital
Hefei, Anhui, China
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
Lu'an People's Hospital of Anhui Province
Lu'an, Anhui, China
The First Affiliated Hospital of Wannan Medical College
Wuhu, Anhui, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
Fujian Cancer Hospital
Fuzhou, Fujian, China
The second hospital of Lanzhou university
Lanzhou, Gansu, China
Gansu Provincial Cancer Hospital
Lanzhou, Gansu, China
Dongguan People's Hospital
Dongguan, Guangdong, China
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
Guanxi Medical University Cancer Hospital
Nanning, Guangxi, China
The People's Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi, China
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
The 2nd Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
Nanyang Central Hospital
Nanyang, Henan, China
Puyang People's Hospital
Puyang, Henan, China
The First Affiliated Hospital of Xinxiang Medical University
Weihui, Henan, China
Xinyang Central Hospital
Xiangyang, Henan, China
Henan Cancer hospital
Zhengzhou, Henan, China
The First Hospital of Zhengzhou University
Zhengzhou, Henan, China
Henan Provincial People's Hospital
Zhengzhou, Henan, China
Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Hubei Cancer Hospital
Wuhan, Hubei, China
Xiangyang Central Hospital
Xiangyang, Hubei, China
Hunan Cancer Hospital
Changsha, Hunan, China
Hunan Provincial Cancer Hospital
Changsha, Hunan, China
Chenzhou No.1 People's Hospital
Chenzhou, Hunan, China
Yueyang Central Hospital
Yueyang, Hunan, China
Zhuzhou Central Hospital
Zhuzhou, Hunan, China
The Affiliated Hospital of Inner Mongolia Medical University
Hohhot, Inner Mongolia, China
The First People's Hospital of Changzhou
Changzhou, Jiangsu, China
The First People's Hospital of Lianyunguang
Lianyungang, Jiangsu, China
Jiangsu Cancer Hospital
Nanjing, Jiangsu, China
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
The first affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Xuzhou Central Hospital
Xuzhou, Jiangsu, China
Northern Jiangsu People's Hosipital
Yangzhou, Jiangsu, China
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
The Third Bethune hospital of Jilin University
Changchun, Jilin, China
Affiliated Zhongshan hospital of Dalian university
Dalian, Liaoning, China
The second hospital of Dalin medical university
Dalian, Liaoning, China
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China
Nanjing Drum Tower Hospital
Nanjing, Nanjing, China
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, China
Qinghai University Affiliated Hospital
Xining, Qinghai, China
The First Affiliated Hospital Of XI'AN Jiaotong University
Xi'an, Shaanxi, China
Jinan Central Hospital
Jinan, Shandong, China
Shandong Cancer Hospital
Jinan, Shandong, China
Linyi People's Hospital
Linyi, Shandong, China
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
Renji Hospital, Medical College, Shanghai Jiaotong University
Shanghai, Shanghai Municipality, China
Shanxi Cancer hospital
Taiyuan, Shanxi, China
Shanxi Bethune Hospital
Taiyuan, Shanxi, China
The Seventh Affiliated Hospital,Sun Yat-sen University
Guangdong, Shenzhen, China
Sichuan Cancer Hospital
Chengdu, Sichuan, China
West China Hospital of Sichuan University
Chengdu, Sichuan, China
Yunnan Cancer Hospital
Kunming, Yunnan, China
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China
The First Hospital of Jiaxing
Jiaxing, Zhejiang, China
Jinhua Municipal Central Hospital
Jinhua, Zhejiang, China
Taizhou Hospital of Zhejiang Province
Taizhou, Zhejiang, China
Taizhou Central Hospital
Taizhou, Zhejiang, China
The firsr Affiliated hospital of Wenzhou medical university
Wenzhou, Zhejiang, China
National Cancer Center Hospital East
Kashiwa-shi, Chiba, Japan
National Hospital Organization Shikoku Cancer Center
Matsuyama, Ehime, Japan
Gifu University Hospital
Gifu, Gifu, Japan
Gunma Prefectural Cancer Center
Ota-Shi, Gunma, Japan
National Hospital Organization Kure Medical Center and Chugoku Cancer Center
Kure, Hirosima [Hiroshima], Japan
Teine Keijinkai Hospital
Sapporo, Hokkaido, Japan
National Hospital Organization Kyushu Cancer Center
Fukuoka, Hukuoka [Fukuoka], Japan
Hyogo Cancer Center
Akashi, Hyōgo, Japan
Kobe City Medical Center General Hospital
Kobe, Hyōgo, Japan
St. Marianna University Hospital
Kawasaki, Kanagawa, Japan
Yokohama City University Medical Center
Yokohama, Kanagawa, Japan
Kanagawa Cancer Center
Yokohama, Kanagawa, Japan
Kochi Health Sciences Center
Kochi, Koti [Kochi], Japan
Osaka Prefectural Hospital Organization - Osaka International Cancer Institute
Osaka, Osaka, Japan
Kindai University Hospital
Osakasayama-Shi, Osaka, Japan
The University of Osaka Hospital
Suita-shi, Osaka, Japan
Saitama Medical University - International Medical Center
Hidaka-Shi, Saitama, Japan
Saitama Prefectural Cancer Center
Kitaadachi-Gun, Saitama, Japan
Chiba Cancer Center
Chiba, Tiba [Chiba], Japan
University of Tokyo Hospital
Bunkyō-Ku, Tokyo, Japan
Tokyo Metropolitan Komagome Hospital
Bunkyō-Ku, Tokyo, Japan
Cancer Institute Hospital of JFCR
Koto, Tokyo, Japan
National Cancer Center Hospital
Tokyo, Tsukiji, Chuo-ku, Japan