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

NCT ID: NCT04492293

Last Updated: 2024-02-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

115 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-27

Study Completion Date

2025-06-30

Brief Summary

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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

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bladder urothelial cancer

Conditions

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Bladder Urothelial Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ICP-192

ICP-192

Group Type EXPERIMENTAL

ICP-192

Intervention Type DRUG

ICP-192 is a white, round, uncoated table

Interventions

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ICP-192

ICP-192 is a white, round, uncoated table

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Signed the ICF and Age ≥ 18 years old, either sex.
2. ECOG ≤ 1.
3. Life expectancy of at least 3 months.
4. Histologically confirmed unresectable or metastatic bladder urothelial cancinoma.
5. At least one measurable lesion as the target lesion at screening assessed according to RECIST V1.1

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing InnoCare Pharma Tech Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jun Guo

Role: PRINCIPAL_INVESTIGATOR

Peking University Cancer Hospital & Institute

Locations

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The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

Site Status RECRUITING

Peking University First Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

The fifth Medical Center of People's Liberation Army General Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Site Status RECRUITING

Lanzhou University Second Hospital

Lanzhou, Gansu, China

Site Status RECRUITING

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

Site Status RECRUITING

Union Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology

Wuhan, Hubei, China

Site Status RECRUITING

Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology

Wuhan, Hubei, China

Site Status RECRUITING

Hunan Cancer Hospital

Changsha, Hunan, China

Site Status RECRUITING

The First Affiliated Hospital of Suzhou University

Suzhou, Jiangsu, China

Site Status RECRUITING

The First Hospital of JiLin University

Jilin, Jilin, China

Site Status RECRUITING

Liaoning Cancer Hospital & Institute

Shenyang, Liaoning, China

Site Status RECRUITING

Shandong University Qilu Hospital

Jinan, Shandong, China

Site Status RECRUITING

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

First Hospital of Shanxi Medical University

Taiyuan, Shanxi, China

Site Status RECRUITING

Sichuan Cancer Hospital

Chengdu, Sichuan, China

Site Status RECRUITING

Tianjin Medical University Cancer Institute & Hospital

Tianjin, Tianjin Municipality, China

Site Status RECRUITING

The Second Hospital of Tianjin Medical University

Tianjin, Tianjin Municipality, China

Site Status RECRUITING

The First Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Site Status RECRUITING

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Site Status RECRUITING

Zhejiang Provincial People's Hospital

Hangzhou, Zhejing, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jun Guo

Role: CONTACT

010-88196348

Facility Contacts

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Chaozhao Liang

Role: primary

Zisong He

Role: primary

Lijun Chen

Role: primary

Jun Guo

Role: primary

010-88196348

Weiyang He

Role: primary

Li Yang

Role: primary

Hui Chen

Role: primary

Xiaoping Zhang

Role: primary

Shaogang Wang

Role: primary

Weiqing Han

Role: primary

Yuhua Huang

Role: primary

Ziling Liu

Role: primary

Bin Hu

Role: primary

Benkang Shi

Role: primary

Danfeng Xu

Role: primary

Xiaoming Cao

Role: primary

Liao Hong

Role: primary

Xin Yao

Role: primary

Hailong Hu

Role: primary

Liping Xie

Role: primary

Shaoxing Zhu

Role: primary

Haiying Dong

Role: primary

Other Identifiers

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ICP-CL-00302

Identifier Type: -

Identifier Source: org_study_id

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