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

February 22, 2024 updated by: Beijing InnoCare Pharma Tech Co., Ltd.

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.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

bladder urothelial cancer

Study Type

Interventional

Enrollment (Estimated)

115

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Anhui
      • Hefei, Anhui, China, 230000
        • Recruiting
        • The First Affiliated Hospital of Anhui Medical University
        • Contact:
          • Chaozhao Liang
    • Beijing
      • Beijing, Beijing, China, 100142
        • Recruiting
        • Beijing Cancer Hospital
        • Contact:
      • Beijing, Beijing, China, 100035
        • Recruiting
        • Peking University First Hospital
        • Contact:
          • Zisong He
      • Beijing, Beijing, China, 100071
        • Recruiting
        • The Fifth Medical Center of People's Liberation Army General Hospital
        • Contact:
          • Lijun Chen
    • Chongqing
      • Chongqing, Chongqing, China, 400016
        • Recruiting
        • The First Affiliated Hospital of Chongqing Medical University
        • Contact:
          • Weiyang He
    • Gansu
      • Lanzhou, Gansu, China, 730030
        • Recruiting
        • Lanzhou University Second Hospital
        • Contact:
          • Li Yang
    • Heilongjiang
      • Ha'erbin, Heilongjiang, China, 150081
        • Recruiting
        • Harbin Medical University Cancer Hospital
        • Contact:
          • Hui Chen
    • Hubei
      • Wuhan, Hubei, China, 430022
        • Recruiting
        • Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
        • Contact:
          • Xiaoping Zhang
      • Wuhan, Hubei, China, 430030
        • Recruiting
        • Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
        • Contact:
          • Shaogang Wang
    • Hunan
      • Changsha, Hunan, China, 410013
        • Recruiting
        • Hunan Cancer Hospital
        • Contact:
          • Weiqing Han
    • Jiangsu
      • Suzhou, Jiangsu, China, 215006
        • Recruiting
        • The First Affiliated Hospital of Suzhou University
        • Contact:
          • Yuhua Huang
    • Jilin
      • Jilin, Jilin, China, 130021
        • Recruiting
        • The First Hospital of Jilin University
        • Contact:
          • Ziling Liu
    • Liaoning
      • Shenyang, Liaoning, China, 110801
        • Recruiting
        • Liaoning Cancer Hospital & Institute
        • Contact:
          • Bin Hu
    • Shandong
      • Jinan, Shandong, China, 250012
        • Recruiting
        • Shandong University Qilu Hospital
        • Contact:
          • Benkang Shi
    • Shanghai
      • Shanghai, Shanghai, China, 200025
        • Recruiting
        • Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
        • Contact:
          • Danfeng Xu
    • Shanxi
      • Taiyuan, Shanxi, China, 030001
        • Recruiting
        • First Hospital of Shanxi Medical University
        • Contact:
          • Xiaoming Cao
    • Sichuan
      • Chengdu, Sichuan, China, 610000
        • Recruiting
        • Sichuan Cancer Hospital
        • Contact:
          • Liao Hong
    • Tianjin
      • Tianjin, Tianjin, China, 300060
        • Recruiting
        • Tianjin Medical University Cancer Institute & Hospital
        • Contact:
          • Xin Yao
      • Tianjin, Tianjin, China, 300211
        • Recruiting
        • The Second Hospital of Tianjin Medical University
        • Contact:
          • Hailong Hu
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310022
        • Recruiting
        • Zhejiang Cancer Hospital
        • Contact:
          • Shaoxing Zhu
      • Hangzhou, Zhejiang, China, 310003
        • Recruiting
        • The First Affiliated Hospital of Zhejiang University School of Medicine
        • Contact:
          • Liping Xie
    • Zhejing
      • Hangzhou, Zhejing, China, 310014
        • Recruiting
        • Zhejiang Provincial People's Hospital
        • Contact:
          • Haiying Dong

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ICP-192
Drug: ICP-192
ICP-192 is a white, round, uncoated table

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ORR
Time Frame: From the time of first dose until objective disease progression, an average of 6 months
Objective Response Rate
From the time of first dose until objective disease progression, an average of 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
DOR
Time Frame: From the time of first dose until objective disease progression, an average of 6 months
Duration of response
From the time of first dose until objective disease progression, an average of 6 months
DCR
Time Frame: From the time of first dose until objective disease progression, an average of 6 months
Disease Control Rate
From the time of first dose until objective disease progression, an average of 6 months
PFS
Time Frame: From the time of first dose until objective disease progression, an average of 6 months
Progression Free Survival
From the time of first dose until objective disease progression, an average of 6 months
OS
Time Frame: From the time of first dose until objective disease progression, an average of 1 months
Overall survival
From the time of first dose until objective disease progression, an average of 1 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing InnoCare Pharma Tech Co., Ltd.

Investigators

  • Principal Investigator: Jun Guo, Peking University Cancer Hospital & Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 27, 2020

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

June 30, 2025

Study Registration Dates

First Submitted

July 23, 2020

First Submitted That Met QC Criteria

July 28, 2020

First Posted (Actual)

July 30, 2020

Study Record Updates

Last Update Posted (Estimated)

February 26, 2024

Last Update Submitted That Met QC Criteria

February 22, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • ICP-CL-00302

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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