An Efficacy and Safety Study of ICP-192 in Subjects With Bladder Urothelial Cancer
- Registration Number
- NCT04492293
- Lead Sponsor
- Beijing InnoCare Pharma Tech Co., Ltd.
- Brief Summary
This is a phase 2, multicenter, single arm, open-lable study of ICP-192. The purpose of this study is to evaluate efficacy of ICP-192 in subjects with surgically unresectable or metastatic bladder urothelial cancer.
- Detailed Description
bladder urothelial cancer
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 115
Not provided
- Prior treatment with selective FGFR inhibitors or FGFR antibodies.
- Any corneal or retinal abnormalities that may result in an increased risk of ocular toxicity.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description ICP-192 ICP-192 ICP-192
- Primary Outcome Measures
Name Time Method ORR From the time of first dose until objective disease progression, an average of 6 months Objective Response Rate
- Secondary Outcome Measures
Name Time Method DCR From the time of first dose until objective disease progression, an average of 6 months Disease Control Rate
PFS From the time of first dose until objective disease progression, an average of 6 months Progression Free Survival
DOR From the time of first dose until objective disease progression, an average of 6 months Duration of response
OS From the time of first dose until objective disease progression, an average of 1 months Overall survival
Trial Locations
- Locations (22)
Liaoning Cancer Hospital & Institute
π¨π³Shenyang, Liaoning, China
The Second Hospital of Tianjin Medical University
π¨π³Tianjin, Tianjin, China
The First Affiliated Hospital of Zhejiang University School of Medicine
π¨π³Hangzhou, Zhejiang, China
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
π¨π³Shanghai, Shanghai, China
The First Affiliated Hospital of Anhui Medical University
π¨π³Hefei, Anhui, China
Lanzhou University Second Hospital
π¨π³Lanzhou, Gansu, China
Harbin Medical University Cancer Hospital
π¨π³Ha'erbin, Heilongjiang, China
Hunan Cancer Hospital
π¨π³Changsha, Hunan, China
Shandong University Qilu Hospital
π¨π³Jinan, Shandong, China
Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
π¨π³Wuhan, Hubei, China
Sichuan Cancer Hospital
π¨π³Chengdu, Sichuan, China
Tianjin Medical University Cancer Institute & Hospital
π¨π³Tianjin, Tianjin, China
Zhejiang Provincial People's Hospital
π¨π³Hangzhou, Zhejing, China
Zhejiang Cancer Hospital
π¨π³Hangzhou, Zhejiang, China
The fifth Medical Center of People's Liberation Army General Hospital
π¨π³Beijing, Beijing, China
Peking University First Hospital
π¨π³Beijing, Beijing, China
The First Affiliated Hospital of Chongqing Medical University
π¨π³Chongqing, Chongqing, China
Beijing Cancer Hospital
π¨π³Beijing, Beijing, China
Union Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
π¨π³Wuhan, Hubei, China
The First Hospital of JiLin University
π¨π³Jilin, Jilin, China
The First Affiliated Hospital of Suzhou University
π¨π³Suzhou, Jiangsu, China
First Hospital of Shanxi Medical University
π¨π³Taiyuan, Shanxi, China