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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Cretostimogene Grenadenorepvec
Biological/VaccineEngineered Oncolytic Adenovirus
n-dodecyl-B-D-maltoside
Other interventionTransduction-enhancing agent
Treatment groups
16 Participants
are divided into 1 treatment groupGroup A: CretostimogeneExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Complete response rate at any time in BCG-unresponsive high-risk NMIBC with or without Ta/T1 papillary tumors including CIS
Time frame
36 monthsSecondary outcomes
1
Duration of response (DOR)
Time from first documented objective response to disease progression or death from any cause.
Time frame
36 months2
Assess high-grade reoccurrence free survival (RFS)
Time from first treatment to first recurrence of high-grade disease or death from any cause.
Time frame
36 months3
Assess progression free survival (PFS)
Time from first treatment to tumor progression or death from any cause.
Time frame
36 months4
Complete response rate at 12, 24, and 36 months
Proportion of patients achieving complete response at 12, 24, and 36 months.
Time frame
Assessed at 12, 24, and 36 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov