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Trial Title:
Brief Title: Phase 2 Study to Evaluate Safety and Efficacy of Cretostimogene Grenadenorepvec in High-Risk NMIBC
NCT ID:
NCT06567743
Condition:
High-Risk Non-Muscle-Invasive Bladder Cancer
Conditions: Official terms:
Urinary Bladder Neoplasms
Non-Muscle Invasive Bladder Neoplasms
Conditions: Keywords:
Bladder Cancer
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Cretostimogene Grenadenorepvec
Description:
Cohort A, Arm 1 and 2
Arm group label:
Experimental: Cohort A, Arm 1
Arm group label:
Experimental: Cohort A, Arm 2
Other name:
CG0070
Intervention type:
Drug
Intervention name:
n-dodecyl-B-D-maltoside
Description:
Transduction-enhancing agent
Arm group label:
Experimental: Cohort A, Arm 1
Arm group label:
Experimental: Cohort A, Arm 2
Other name:
DDM
Summary:
This is a Phase 2, Multi-Arm, Multi-Cohort, Open-Label Study to Evaluate the Safety and
Efficacy of Cretostimogene Grenadenorepvec in Participants with High-Risk
Non-Muscle-Invasive Bladder Cancer.
Detailed description:
In Cohort A, up to 50 participants will be enrolled with pathologically confirmed,
CIS-containing, high-risk NMIBC (i.e., CIS with or without concomitant Ta/T1) who are
naïve to BCG treatment. Participants will be randomized 1:1 to receive DDM and
cretostimogene via the current (Arm 1) or an alternative instillation procedure (Arm 2).
Cretostimogene and DDM will be administered as a weekly induction course for the first 6
weeks with a reinduction course administered to patients who have CIS and/or high-grade
Ta disease at the 3-month evaluation. Following induction, if no high-grade disease is
detected, maintenance treatment will begin. This consists of a cycle of three weekly
treatments every three months during the first year, and every six months during the
second year, with an optional extension to the third year following the same six-month
schedule.
Disease status will be assessed using urine cytology, complete bladder visualization
(e.g., cystoscopy), upper tract assessment and and directed TURBT/biopsy (if indicated)
every 3 months for the first 2 years after randomization and then every 6 months for a
further 2 years or until disease recurrence.
Criteria for eligibility:
Criteria:
Cohort A Key Inclusion Criteria:
- Pathologically confirmed BCG-naïve, CIS-containing (i.e., CIS with or without
concomitant HG Ta/T1) high-risk NMIBC within 90 days of randomization.
- Participants with BCG-naïve NMIBC should have either:
- No prior treatment with BCG OR
- No treatment with BCG within the past 24 months prior to current pathological
diagnosis OR
- A maximum of 1 or 2 doses of BCG within the past 24 months prior to current
pathological diagnosis.
- All visible disease must be resected, and all CIS resected or fulgurated, as
feasible within 90 days prior to randomization.
- Acceptable baseline organ function.
Key Exclusion Criteria:
- Current or past history of muscle-invasive, locally advanced or metastatic bladder
cancer.
- High-grade disease in the upper urinary tract or prostatic urethra within 24 months
of randomization or any history of muscle-invasive, locally advanced or metastatic
disease in the upper urinary tract.
- Significant immunodeficiency.
- Pregnant or breastfeeding.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Southern Urology (Urology America)
Address:
City:
Lafayette
Zip:
70508
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jason Bourque, MD
Phone:
337-422-3738
Email:
jasonbourque@gmail.com
Investigator:
Last name:
Jason Bourque, MD
Email:
Principal Investigator
Facility:
Name:
The Conrad Pearson Clinic (Urology America)
Address:
City:
Germantown
Zip:
38138
Country:
United States
Status:
Recruiting
Contact:
Last name:
Michael Granieri, MD
Phone:
901-236-0957
Email:
mgranieri@conradpearson.com
Investigator:
Last name:
Michael Granieri, MD
Email:
Principal Investigator
Facility:
Name:
Urology Austin, PLLC (Urology America)
Address:
City:
Austin
Zip:
78745
Country:
United States
Status:
Recruiting
Contact:
Last name:
Brian Mazzarella, MD
Phone:
512-410-3773
Email:
brian.mazzarella@urologyaustin.com
Investigator:
Last name:
Brian Mazzarella
Email:
Principal Investigator
Start date:
September 16, 2024
Completion date:
December 30, 2027
Lead sponsor:
Agency:
CG Oncology, Inc.
Agency class:
Industry
Source:
CG Oncology, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06567743
