clinical trial · NCT07283835
Study of Cretostimogene Given in Patients With Non-Muscle Invasive Bladder Cancer ,Unresponsive to Bacillus-Calmette-Guerin
Lepu Biopharma Co., Ltd.·phase2·recruiting·n = 16
Non Muscle Invasive Bladder CancerHigh-grade Ta/ T1 Papillary Disease Bladder CancerCretostimogene Grenadenorepvecn-dodecyl-B-D-maltoside
brief 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.
started
Dec 4, 2025
primary completion
Dec 31, 2027
completion
Dec 31, 2028
last updated
Apr 23, 2026
detailed description
An open-label trial designed to evaluate Cretostimogene + DDM in patients with NMIBC who have failed prior BCG therapy. Single treatment arm that enrolled patients with carcinoma in situ with or without concomitant high-grade Ta or T1 papillary disease.
official title
A Single-arm, Open-label, Multicenter Phase II Clinical Study to Evaluate the Efficacy and Safety of Cretostimogene Grenadenorepvec in Patients With BCG-unresponsive High-risk Non-Muscle Invasive Bladder Cancer
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol