Clinical trial · Interventional
An Efficacy and Safety Study of ICP-192 in Subjects With Bladder Urothelial Cancer
A Phase 2, Multicenter, Single Arm, Open-lable Study of ICP-192 in Subjects With Surgically Unresectable or Metastatic Bladder Urothelial Cancer With FGFR Genetic Aberrations.
NCT04492293CI-TRIAL-00074371unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Urothelial Cancer | Bladder Urothelial Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ICP-192 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ICP-192
- description
- ICP-192
- interventionNames
- Drug: ICP-192
Primary outcomes (1)
- measure
- ORR
- timeFrame
- From the time of first dose until objective disease progression, an average of 6 months
- description
- Objective Response Rate
Secondary outcomes (4)
- measure
- DOR
- timeFrame
- From the time of first dose until objective disease progression, an average of 6 months
- description
- Duration of response
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.