Bladder Urothelial Cancer
Conditions
Brief 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.
Detailed description
bladder urothelial cancer
Interventions
DRUGICP-192
ICP-192 is a white, round, uncoated table
Sponsors
Beijing InnoCare Pharma Tech Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ORR | From the time of first dose until objective disease progression, an average of 6 months | Objective Response Rate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| DOR | From the time of first dose until objective disease progression, an average of 6 months | Duration of response |
| DCR | From the time of first dose until objective disease progression, an average of 6 months | Disease Control Rate |
| PFS | From the time of first dose until objective disease progression, an average of 6 months | Progression Free Survival |
| OS | From the time of first dose until objective disease progression, an average of 1 months | Overall survival |
Countries
China
Contacts
Primary ContactJun Guo
Outcome results
None listed