Purpose

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

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Single Arm
Patients with carcinoma in situ with or without concomitant high-grade Ta or T1 papillary disease. CG0070 will be administered intravesically (IVE) following a sequence of bladder washes with 5% DDM and normal saline. CG0070 will be administered weekly x 6 on Weeks 1, 2, 3, 4, 5, and 6. If the patient 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 patient will receive 3 weekly treatments. Beginning at Week 25, patients will receive weekly x 3 treatments every 12 weeks through week 49then every 24 weeks thereafter.
  • Biological: CG0070
    Engineered Oncolytic Adenovirus
  • Other: n-dodecyl-B-D-maltoside
    Transduction-enhancing agent.
    Other names:
    • DDM

Recruiting Locations

University of Kansas
Kansas City, Kansas 66160

More Details

Status
Recruiting
Sponsor
CG Oncology, Inc.

Study Contact

Angelica Craighead
415-640-2322
Angelica.Craighead@cgoncology.com

Detailed Description

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.