Evaluating ICP-192 for 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.

This study is testing a new treatment called ICP-192 to see if it can help people with advanced bladder cancer that can't be surgically removed.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 115 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Beijing InnoCare Pharma Tech Co., Ltd. (Industry-sponsored)
• Locations: 22 sites (Hefei, Anhui and 21 other locations)
• Trial ID: NCT04492293 on ClinicalTrials.gov

What this trial studies

This phase 2, multicenter, single-arm, open-label study aims to assess the efficacy and safety of ICP-192 in patients with surgically unresectable or metastatic bladder urothelial cancer. Participants will receive the treatment and be monitored for outcomes related to tumor response and safety. The study will include patients who have at least one measurable lesion and meet specific eligibility criteria. The goal is to determine if ICP-192 can provide a beneficial effect in this patient population.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with histologically confirmed unresectable or metastatic bladder urothelial carcinoma.

Not a fit: Patients who have previously received selective FGFR inhibitors or have ocular abnormalities may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new therapeutic option for patients with advanced bladder urothelial cancer.

How similar studies have performed: While this approach is being evaluated in this specific context, similar studies targeting FGFR pathways have shown promise in other cancer types.

Eligibility 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.

Where this trial is running

Hefei, Anhui and 21 other locations

• The First Affiliated Hospital of Anhui Medical University — Hefei, Anhui, China (Recruiting)
• Peking University First Hospital — Beijing, Beijing, China (Recruiting)
• The fifth Medical Center of People's Liberation Army General Hospital — Beijing, Beijing, China (Recruiting)
• Beijing Cancer Hospital — Beijing, Beijing, China (Recruiting)
• The First Affiliated Hospital of Chongqing Medical University — Chongqing, Chongqing, China (Recruiting)
• Lanzhou University Second Hospital — Lanzhou, Gansu, China (Recruiting)
• Harbin Medical University Cancer Hospital — Ha'erbin, Heilongjiang, China (Recruiting)
• Union Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology — Wuhan, Hubei, China (Recruiting)
• Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology — Wuhan, Hubei, China (Recruiting)
• Hunan Cancer Hospital — Changsha, Hunan, China (Recruiting)
• The First Affiliated Hospital of Suzhou University — Suzhou, Jiangsu, China (Recruiting)
• The First Hospital of JiLin University — Jilin, Jilin, China (Recruiting)
• Liaoning Cancer Hospital & Institute — Shenyang, Liaoning, China (Recruiting)
• Shandong University Qilu Hospital — Jinan, Shandong, China (Recruiting)
• Ruijin Hospital, Shanghai Jiao Tong University School of Medicine — Shanghai, Shanghai, China (Recruiting)
• First Hospital of Shanxi Medical University — Taiyuan, Shanxi, China (Recruiting)
• Sichuan Cancer Hospital — Chengdu, Sichuan, China (Recruiting)
• Tianjin Medical University Cancer Institute & Hospital — Tianjin, Tianjin, China (Recruiting)
• The Second Hospital of Tianjin Medical University — Tianjin, Tianjin, China (Recruiting)
• The First Affiliated Hospital of Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (Recruiting)
• Zhejiang Cancer Hospital — Hangzhou, Zhejiang, China (Recruiting)
• Zhejiang Provincial People's Hospital — Hangzhou, Zhejing, China (Recruiting)

Study contacts

• Principal investigator: Jun Guo — Peking University Cancer Hospital & Institute
• Study coordinator: Jun Guo

Conditions Bladder Urothelial Cancer