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Clinical Trials in China / NCT07283835
Recruiting Phase 2

Study of Cretostimogene Given in Patients With Non-Muscle Invasive Bladder Cancer ,Unresponsive to Bacillus-Calmette-Guerin

NCT07283835 · tracked via the Priya Life Science China tracker
Sponsor
Lepu Biopharma Co., Ltd.
Phase
Phase 2
Started
2025-12-04
Last updated
2026-04-23

Condition(s) studied

Non Muscle Invasive Bladder CancerHigh-grade Ta/ T1 Papillary Disease Bladder Cancer

Investigational drug(s) / intervention(s)

Cretostimogene Grenadenorepvecn-dodecyl-B-D-maltoside

Cretostimogene Grenadenorepvec: Engineered Oncolytic Adenovirus

n-dodecyl-B-D-maltoside: Transduction-enhancing agent

Study summary

This study aims to evaluate the efficacy and safety of Cretostimogene 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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: In order to be eligible for participation in this trial, the patient must: 1. 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. 2. Have Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. 3. Have all Ta and/or T1 disease resected and all CIS resected or fulgurated, as feasible, prior to study treatment. 4. Demonstrate adequate organ function. 5. 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 Patients who withdraw consent for these procedures will be withdrawn from the trial. 6. Ineligible to receive radical cystectomy or refusal of radical cystectomy according to Investigator assessment. Exclusion Criteria: 1. Has current or past history of muscle invasive (T2 or higher stage) or locally advanced (T3/T4, any N) or metastatic bladder cancer. 2. History of urothelial carcinoma in the upper genitourinary tract (kidney, renal collecting system, ureter) or in the prostatic urethra, including urethral CIS, within 24 months prior to enrollment. 3. Has received systemic anti-cancer therapy, including investigational agents. 4. Has had prior systemic treatment (with the exception of checkpoint inhibitor therapy), radiation therapy, or surgery for bladder cancer other than TURBT or bladder biopsies. 5. Has any of the following within the 6 months prior to starting study treatment: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, cerebrovascular accident, pulmonary embolus, uncontrolled hypertension, or uncontrolled congestive heart failure. 6. Cannot tolerate study-related biopsies, IVE administration, or 1-hour bladder hold of Cretostimogene.

Primary outcome measure(s)

Trial sites (14)

FacilityCityRegionStatus
Peking University First Hospital (First Clinical Medical School of Peking University) Beijing Beijing Municipality Recruiting
Chongqing University Cancer Hospital Chongqing Chongqing Municipality Recruiting
Fujian Cancer Hospital Fuzhou Fujian Recruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Wuhan Hubei Recruiting
Hunan Cancer Hospital Changsha Hunan Recruiting
The Affiliated Drum Tower Hospital of Nanjing University Medical School Nanjing Jiangsu Recruiting
The First Hospital of China Medical University Shenyang Liaoning Recruiting
Qilu Hospital of Shandong University Jinan Shandong Recruiting
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine Shanghai Shanghai Municipality Recruiting
Fudan University Shanghai Cancer Center Shanghai Shanghai Municipality Recruiting
West China Hospital, Sichuan University Chengdu Sichuan Recruiting
The Second Hospital of Tianjin Medical University Tianjin Tianjin Municipality Recruiting
The First Affiliated Hospital, Zhejiang University School of Medicine Hangzhou Zhejiang Recruiting
The First Affiliated Hospital of Wenzhou Medical University Wenzhou Zhejiang Recruiting

More Lepu Biopharma Co., Ltd. trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07283835 on ClinicalTrials.gov ↗ ← All trials in China