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

InnoCare Pharma

Status and phase: Enrolling; Phase 2

Conditions: Bladder Urothelial Cancer

Treatments: Drug: ICP-192

Study type: Interventional

Funder types: Industry

Identifiers

NCT04492293

ICP-CL-00302

Details and patient eligibility

About

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.

Full description

bladder urothelial cancer

Enrollment: 115 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

115 participants in 1 patient group

ICP-192

Experimental group

Description:

ICP-192

Treatment:

Drug: ICP-192