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

Beijing InnoCare Pharma Tech Co., Ltd.115 enrolled

Overview

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.

bladder urothelial cancer

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

115

Conditions

Bladder Urothelial Cancer

Interventions

ICP-192DRUG

ICP-192 is a white, round, uncoated table

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (22)

Outcomes

Primary Outcomes

ORR

Objective Response Rate

Time frame: From the time of first dose until objective disease progression, an average of 6 months

Secondary Outcomes

DOR

Duration of response

Time frame: From the time of first dose until objective disease progression, an average of 6 months

DCR

Disease Control Rate

Time frame: From the time of first dose until objective disease progression, an average of 6 months

PFS

Progression Free Survival

Time frame: From the time of first dose until objective disease progression, an average of 6 months

Overall survival

Time frame: From the time of first dose until objective disease progression, an average of 1 months

Central Contacts

Jun Guo

CONTACT

010-88196348 guoj307@126.com

Data from ClinicalTrials.gov

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