An Efficacy and Safety Study of ICP-192 in Subjects With Bladder Urothelial Cancer
A Phase 2, Multicenter, Single Arm, Open-lable Study of ICP-192 in Subjects With Surgically Unresectable or Metastatic Bladder Urothelial Cancer With FGFR Genetic Aberrations.
1 other identifier
interventional
115
1 country
22
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started May 2020
Longer than P75 for phase_2
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 27, 2020
CompletedFirst Submitted
Initial submission to the registry
July 23, 2020
CompletedFirst Posted
Study publicly available on registry
July 30, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2025
CompletedFebruary 26, 2024
February 1, 2024
4.6 years
July 23, 2020
February 22, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
ORR
Objective Response Rate
From the time of first dose until objective disease progression, an average of 6 months
Secondary Outcomes (4)
DOR
From the time of first dose until objective disease progression, an average of 6 months
DCR
From the time of first dose until objective disease progression, an average of 6 months
PFS
From the time of first dose until objective disease progression, an average of 6 months
OS
From the time of first dose until objective disease progression, an average of 1 months
Study Arms (1)
ICP-192
EXPERIMENTALICP-192
Interventions
Eligibility Criteria
You may qualify if:
- Signed the ICF and Age ≥ 18 years old, either sex.
- ECOG ≤ 1.
- Life expectancy of at least 3 months.
- Histologically confirmed unresectable or metastatic bladder urothelial cancinoma.
- At least one measurable lesion as the target lesion at screening assessed according to RECIST V1.1
You may not qualify if:
- Prior treatment with selective FGFR inhibitors or FGFR antibodies.
- Any corneal or retinal abnormalities that may result in an increased risk of ocular toxicity.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (22)
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230000, China
Peking University First Hospital
Beijing, Beijing Municipality, 100035, China
The fifth Medical Center of People's Liberation Army General Hospital
Beijing, Beijing Municipality, 100071, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400016, China
Lanzhou University Second Hospital
Lanzhou, Gansu, 730030, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150081, China
Union Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, 430022, China
Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, 430030, China
Hunan Cancer Hospital
Changsha, Hunan, 410013, China
The First Affiliated Hospital of Suzhou University
Suzhou, Jiangsu, 215006, China
The First Hospital of JiLin University
Jilin, Jilin, 130021, China
Liaoning Cancer Hospital & Institute
Shenyang, Liaoning, 110801, China
Shandong University Qilu Hospital
Jinan, Shandong, 250012, China
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200025, China
First Hospital of Shanxi Medical University
Taiyuan, Shanxi, 030001, China
Sichuan Cancer Hospital
Chengdu, Sichuan, 610000, China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, 300060, China
The Second Hospital of Tianjin Medical University
Tianjin, Tianjin Municipality, 300211, China
The First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310003, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022, China
Zhejiang Provincial People's Hospital
Hangzhou, Zhejing, 310014, China
Study Officials
- PRINCIPAL INVESTIGATOR
Jun Guo
Peking University Cancer Hospital & Institute
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 23, 2020
First Posted
July 30, 2020
Study Start
May 27, 2020
Primary Completion
December 31, 2024
Study Completion
June 30, 2025
Last Updated
February 26, 2024
Record last verified: 2024-02