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

  • STATUS
    Recruiting
  • participants needed
    95
  • sponsor
    Beijing InnoCare Pharma Tech Co., Ltd.
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Updated on 19 February 2024
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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

Details
Condition Bladder Urothelial Cancer
Age 18years - 100years
Treatment ICP-192
Clinical Study IdentifierNCT04492293
SponsorBeijing InnoCare Pharma Tech Co., Ltd.
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

Volunteer to enroll and sign informed consent form
Male or female aged at least 18 years
ECOG performance status score 0 or 1
The expected survival time is more than 3 months
Histologically confirmed unresectable or metastatic bladder urothelial cancinoma
Must have measurable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1) at baseline

Exclusion Criteria

Previous treatment with FGFR small molecule inhibitors or antibody drugs
Blood phosphate persistently above ULN within two weeks of the first administration of study drug, and despite medical management
Central nervous system (CNS) metastasis
Has not recovered from reversible toxicity of prior anticancer therapy
Has a history of or current uncontrolled cardiovascular disease
Has impaired wound healing capacity defined as skin/decubitus ulcers, chronic leg ulcers, known gastric ulcers, or unhealed incisions
Any corneal or retinal abnormality likely to increase the risk of eye toxicity
Known active infection with HBV, HCV or HIV
Lactating or pregnant women, or women who will not use contraception during the study and for 180 days after the last dose of study drug if sexually active and able to bear children
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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