Health Trials

About this trial

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 criteria

Qualifiers

Be ≥18 years of age on day of signing informed consent.

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.

Disqualifiers

Has current or past history of muscle invasive (T2 or higher stage) or locally advanced (T3/T4, any N) or metastatic bladder cancer.

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.

Has received systemic anti-cancer therapy, including investigational agents.

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.

Trial design

Treatments tested in this trial

  • Cretostimogene Grenadenorepvec
  • n-dodecyl-B-D-maltoside

Treatment groups

16 Participants
are divided into 1 treatment group

Locations

14
Peking University First Hospital (First Clinical Medical School of Peking University)100034, BeijingBeijing Municipality, China
Chongqing University Cancer Hospital400030, ChongqingChongqing Municipality, China
Fujian Cancer Hospital350014, FuzhouFujian, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology430022, WuhanHubei, China

Sponsors and collaborators

Lepu Biopharma Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov