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.

Eligibility

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.