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

Bladder Urothelial Cancer Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04492293
• Other study ID #: ICP-CL-00302
• Status: Recruiting
• Phase: Phase 2
• Start date: May 27, 2020
• Est. completion date: June 30, 2025

Study information

• Verified date: February 2024
• Source: Beijing InnoCare Pharma Tech Co., Ltd.
• Contact: Jun Guo
• Phone: 010-88196348
• Email: guoj307[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

bladder urothelial cancer

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 115
• Est. completion date: June 30, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bladder Urothelial Cancer

Intervention

Drug:
• ICP-192
ICP-192 is a white, round, uncoated table

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing	Beijing
China	Peking University First Hospital	Beijing	Beijing
China	The fifth Medical Center of People's Liberation Army General Hospital	Beijing	Beijing
China	Hunan Cancer Hospital	Changsha	Hunan
China	Sichuan Cancer Hospital	Chengdu	Sichuan
China	The First Affiliated Hospital of Chongqing Medical University	Chongqing	Chongqing
China	Harbin Medical University Cancer Hospital	Ha'erbin	Heilongjiang
China	The First Affiliated Hospital of Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang
China	Zhejiang Provincial People's Hospital	Hangzhou	Zhejing
China	The First Affiliated Hospital of Anhui Medical University	Hefei	Anhui
China	The First Hospital of JiLin University	Jilin	Jilin
China	Shandong University Qilu Hospital	Jinan	Shandong
China	Lanzhou University Second Hospital	Lanzhou	Gansu
China	Ruijin Hospital, Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai
China	Liaoning Cancer Hospital & Institute	Shenyang	Liaoning
China	The First Affiliated Hospital of Suzhou University	Suzhou	Jiangsu
China	First Hospital of Shanxi Medical University	Taiyuan	Shanxi
China	The Second Hospital of Tianjin Medical University	Tianjin	Tianjin
China	Tianjin Medical University Cancer Institute & Hospital	Tianjin	Tianjin
China	Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology	Wuhan	Hubei
China	Union Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Beijing InnoCare Pharma Tech Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ORR	Objective Response Rate	From the time of first dose until objective disease progression, an average of 6 months
Secondary	DOR	Duration of response	From the time of first dose until objective disease progression, an average of 6 months
Secondary	DCR	Disease Control Rate	From the time of first dose until objective disease progression, an average of 6 months
Secondary	PFS	Progression Free Survival	From the time of first dose until objective disease progression, an average of 6 months
Secondary	OS	Overall survival	From the time of first dose until objective disease progression, an average of 1 months