Trial purpose
Cancer treatment
Tumor type
Genitourinary
Age
18+
Clinical summary
Summary
This is a single arm study for people with non-muscular invasive bladder cancer with carcinoma in situ with or without concomitant high-grade Ta or T1 papillary disease, who have been unresponsive to prior BCG therapy. All participants will receive the same treatment. CG0070 will be administered intravesically (via urethral catheter) following a sequence of bladder washes with 5% DDM (n-dodecyl-B-D-maltoside Transduction-enhancing agent) and normal saline. CG0070 will be administered weekly x 6 on Weeks 1, 2, 3, 4, 5, and 6. If the participant has persistent high-grade disease at Week 13, the patient will receive another cycle of 6 weekly treatments. If there is no disease present at Week 13 (e.g. complete response), then the participant will receive 3 weekly treatments. Beginning at Week 25, participants will receive weekly x3 treatments every 12 weeks through week 49, then every 24 weeks thereafter.
Conditions
This trial is treating people with bladder cancer
Eligibility
Inclusion
- 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
Exclusion
- 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
Inclusion
- You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
- Your cancer has not spread to other parts of the body (localised).
Exclusion
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
CG Oncology, Inc.
Scientific Title
A Phase 3 Study of CG0070 in Patients With Non-Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Bacillus-Calmette-Guerin (BCG)
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