To evaluate the activity of intravesical (IVE) administration of CG0070 in patients with tissue pathology confirmed non-muscular invasive bladder cancer (NMIBC) who have Bacillus-Calmette-Guerin (BCG) unresponsive disease, with either carcinoma in situ with or without Ta/T1 disease
An open-label trial designed to evaluate CG0070 + DDM in patients with NMIBC who have failed
prior BCG therapy. Single treatment arm that will enroll up to 110 patients with carcinoma in
situ with or without concomitant high-grade Ta or T1 papillary disease
BCG failure is defined as a persistent or recurrent disease within 12 months of completion of
adequate BCG therapy.
Overal Status | Start Date | Phase | Study Type |
---|---|---|---|
Recruiting | October 27, 2020 | Phase 3 | Interventional |
Primary Outcome 1 - Measure: Complete response rate in patients with carcinoma in situ (with or without concomitant high-grade Ta or T1 papillary disease)
Primary Outcome 1 - Time Frame: 24 months
Criteria:
Key Inclusion Criteria:
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
- Have pathologically confirmed World Health Organization (WHO) grading system employed
for tumor grading) high-risk NMIBC unresponsive to prior BCG therapy defined as:
Persistent or recurrent CIS alone or with recurrent Ta/T1 (noninvasive papillary
disease/tumor invades the subepithelial connective tissue) disease within 12 months of
completion of adequate BCG therapy
- Received prior adequate BCG therapy as defined as at least one of the following (5+2"
minimum exposure):
1. At least five of six doses of an initial induction course (adequate induction)
plus at least two of three doses of maintenance therapy, OR
2. At least five of six doses of an initial induction course (adequate induction)
plus at least two of six doses of a second induction course.
- Ineligible for radical cystectomy or refusal of radical cystectomy
- Adequate organ function
Key Exclusion Criteria:
- Muscle invasive (T2 or higher stage) or locally advanced (T3/T4, any N) or metastatic
bladder cancer
- Has known upper tract or prostatic urethra malignancy
- Has systemic anti-cancer therapy, including investigational agents, within 4 weeks of
Baseline
- Immuno-deficient due to chronic steroid or other immunosuppressant use, HIV, or prior
organ transplant
- Prior treatment with adenovirus-based cancer therapy
- Clinically significant or active cardiac disease
- Active autoimmune disease
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Gender: All
Minimum Age: 18 Years
Maximum Age: N/A
Healthy Volunteers: No
Name: James Burke, MD
Role: Principal Investigator
Affiliation: CG Oncology, Inc.
Name: Stephanie Harris
Phone: 9494093700
Email: stephanie.harris@cgoncology.com
Facility | Status | Contact |
---|---|---|
University of Toledo Toledo, Ohio 43614 United States |
Recruiting |
Stephanie Smiddy stephanie.smiddy@utoledo.edu |
Urology San Antonio, PA San Antonio, Texas 78229 United States |
Recruiting |
Kehkashan Arshad Kehkashan.arshad@urologysa.com |