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BRIEF TITLE: CG0070 in Patients With Non-Muscular Invasive Bladder Cancer (NMIBC) Unresponsive to Bacillus-Calmette-Guerin (BCG)

A Phase 3 Study of CG0070 in Patients With Non-Muscular Invasive Bladder Cancer (NMIBC) Unresponsive to Bacillus-Calmette-Guerin (BCG)


  • Org Study ID: CG3002S
  • Secondary ID:
  • NCT ID: NCT04452591
  • NCT Alias:
  • Sponsor: CG Oncology, Inc. - Industry
  • Source: CG Oncology, Inc.

Brief Summary

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

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.

Overal Status Start Date Phase Study Type
Recruiting October 27, 2020 Phase 3 Interventional

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 - Time Frame: 24 months

Condition:

  • Non Muscular Invasive Bladder Cancer

Eligibility

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

Official Information

Name: James Burke, MD

Role: Principal Investigator

Affiliation: CG Oncology, Inc.

Overall Contact

Name: Stephanie Harris

Phone: 9494093700

Email: stephanie.harris@cgoncology.com

Locations

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