Study of Cretostimogene Given in Patients With Non-Muscle Invasive Bladder Cancer ,Unresponsive to Bacillus-Calmette-Guerin
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorLepu Biopharma Co., Ltd.
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 groupSponsors and collaborators
Source ClinicalTrials.gov