An Efficacy and Safety Study of ICP-192 in Subjects With Bladder Urothelial Cancer

Phase 2

Recruiting

• Conditions: Bladder Urothelial Cancer
• Interventions: Drug: ICP-192

• 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

Study Timeline

• Study Start: 2020-05-27
• Study First Submitted: 2020-07-23
• Study First Submitted QC: 2020-07-28
• Study First Posted: 2020-07-30
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-22
• Last Update Posted: 2024-02-26
• Primary Completion: 2024-12-31
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 115

Inclusion Criteria

Not provided

Exclusion Criteria

1. Prior treatment with selective FGFR inhibitors or FGFR antibodies.
2. 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)

The First Affiliated Hospital of Anhui Medical University; 🇨🇳 Hefei, Anhui, China

Peking University First Hospital; 🇨🇳 Beijing, Beijing, China

The fifth Medical Center of People's Liberation Army General Hospital; 🇨🇳 Beijing, Beijing, China

Beijing Cancer Hospital; 🇨🇳 Beijing, Beijing, China

The First Affiliated Hospital of Chongqing Medical University; 🇨🇳 Chongqing, Chongqing, China

Lanzhou University Second Hospital; 🇨🇳 Lanzhou, Gansu, China

Harbin Medical University Cancer Hospital; 🇨🇳 Ha'erbin, Heilongjiang, China

Union Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology; 🇨🇳 Wuhan, Hubei, China

Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology; 🇨🇳 Wuhan, Hubei, China

Hunan Cancer Hospital; 🇨🇳 Changsha, Hunan, China

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