Recruiting

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.

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What is being tested

ICP-192

Drug
Who is being recruted

Over 18 Years
+7 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: May 2020
See protocol details

Summary

Principal SponsorBeijing InnoCare Pharma Tech Co., Ltd.
Study ContactJun Guo
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: May 27, 2020

Actual date on which the first participant was enrolled.

bladder urothelial cancer

Official TitleA 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.
NCT04492293
Principal SponsorBeijing InnoCare Pharma Tech Co., Ltd.
Study ContactJun Guo
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

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

115 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

5 inclusion criteria required to participate
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.
Show More Criteria
2 exclusion criteria prevent from participating
Prior treatment with selective FGFR inhibitors or FGFR antibodies.
Any corneal or retinal abnormalities that may result in an increased risk of ocular toxicity.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
ICP-192

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 22 locations

Recruiting

The First Affiliated Hospital of Anhui Medical University

Hefei, ChinaOpen The First Affiliated Hospital of Anhui Medical University in Google Maps
Recruiting

Peking University First Hospital

Beijing, China
Recruiting

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

Beijing, China
Recruiting

Beijing Cancer Hospital

Beijing, China
Recruiting
22 Study Centers