A Single-arm, Open-label, Multicenter Phase II Clinical Study to Evaluate the Efficacy and Safety of CG0070 Injection in Patients With BCG-unresponsive High-risk Non-Muscle Invasive Bladder Cancer
Status: Recruiting
Location: See all (15) locations...
Intervention Type: Other, Biological
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
This study aims to evaluate the efficacy and safety of CG0070 injection in patients with BCG-unresponsive high-risk non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without Ta/T1 papillary tumors.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
⁃ In order to be eligible for participation in this trial, the patient must:
• Be ≥18 years of age on day of signing informed consent.
• \- Patients must have pathologically confirmed BCG-unresponsive non-muscle-invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without concomitant Ta/T1 papillary disease.
• Have Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
• Have all Ta and/or T1 disease resected and all CIS resected or fulgurated, as feasible, prior to study treatment.
• Demonstrate adequate organ function.
• Patients must be willing to comply with study mandated cystoscopies, urine cytology, urograms, biopsies, and other procedures (including TURBT or other resection for all Ta/T1 disease) for the duration of the study. Patients who withdraw consent for these procedures will be withdrawn from the trial.
• Ineligible to receive radical cystectomy or refusal of radical cystectomy according to Investigator assessment.
Locations
Other Locations
China
Peking University First Hospital (First Clinical Medical School of Peking University)
NOT_YET_RECRUITING
Beijing
Hunan Cancer Hospital
NOT_YET_RECRUITING
Changsha
West China Hospital, Sichuan University
NOT_YET_RECRUITING
Chengdu
Chongqing University Cancer Hospital
NOT_YET_RECRUITING
Chongqing
Fujian Cancer Hospital
NOT_YET_RECRUITING
Fuzhou
Sun Yat-sen University Cancer Center
NOT_YET_RECRUITING
Guangzhou
The First Affiliated Hospital, Zhejiang University School of Medicine
NOT_YET_RECRUITING
Hangzhou
Qilu Hospital of Shandong University
NOT_YET_RECRUITING
Jinan
The Affiliated Drum Tower Hospital of Nanjing University Medical School
RECRUITING
Nanjing
Fudan University Shanghai Cancer Center
RECRUITING
Shanghai
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
NOT_YET_RECRUITING
Shanghai
The First Hospital of China Medical University
NOT_YET_RECRUITING
Shenyang
The Second Hospital of Tianjin Medical University
RECRUITING
Tianjin
The First Affiliated Hospital of Wenzhou Medical University
RECRUITING
Wenzhou
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
NOT_YET_RECRUITING
Wuhan
Contact Information
Primary
Program Director
clinicaltrials@lepubiopharma.com
86-21-61637960
Time Frame
Start Date:2025-12-04
Estimated Completion Date:2028-12-31
Participants
Target number of participants:16
Treatments
Experimental: CG0070
Patients with CIS with or without HG Ta/T1 papillary disease. CG0070 will be administered intravesically following a series of bladder washes with 5% DDM and normal saline. CG0070 will be administered weekly for specific schedule per protocol.