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

RECRUITINGPhase 2Sponsored by Beijing InnoCare Pharma Tech Co., Ltd.
Actively Recruiting
PhasePhase 2
SponsorBeijing InnoCare Pharma Tech Co., Ltd.
Started2020-05-27
Est. completion2024-12-31
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT04492293

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.

Eligibility

Age: 18 Years+Healthy volunteers accepted
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.

Conditions2

Bladder Urothelial CancerCancer

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