Status:
RECRUITING
An Efficacy and Safety Study of ICP-192 in Subjects With Bladder Urothelial Cancer
Lead Sponsor:
Beijing InnoCare Pharma Tech Co., Ltd.
Conditions:
Bladder Urothelial Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 uro...
Detailed Description
bladder urothelial cancer
Eligibility Criteria
Inclusion
- Inclusion criteria：
- 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
- Exclusion Criteria:
- Prior treatment with selective FGFR inhibitors or FGFR antibodies.
- Any corneal or retinal abnormalities that may result in an increased risk of ocular toxicity.
Exclusion
Key Trial Info
Start Date :
May 27 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2025
Estimated Enrollment :
115 Patients enrolled
Trial Details
Trial ID
NCT04492293
Start Date
May 27 2020
End Date
June 30 2025
Last Update
February 26 2024
Active Locations (22)
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1
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China, 230000
2
Peking University First Hospital
Beijing, Beijing Municipality, China, 100035
3
The fifth Medical Center of People's Liberation Army General Hospital
Beijing, Beijing Municipality, China, 100071
4
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100142