Brief Title: Study of CG0070 Given in Patients With Non-Muscular Invasive Bladder Cancer ,Unresponsive to Bacillus-Calmette-Guerin

PRIMARY OUTCOMES

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 - Timeframe: 24 months

CONDITION

• Non Muscular Invasive Bladder Cancer

ELIGIBILITY

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):
At least five of six doses of an initial induction course (adequate induction) plus at least two of three doses of maintenance therapy, OR

- 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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: James Burke, MD

Role: Principal Investigator

Affiliation: CG Oncology, Inc.

Overall Contact

Name: James Burke, MD

Phone: 516-456-1415

Email: joann.horn@CGoncology.com

LOCATION