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

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

INTRODUCTION

  • Org Study ID: CG3002S
  • Secondary ID: N/A
  • NTC ID: NCT04452591
  • Sponsor: 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.

  • Overall Status
    Recruiting
  • Start Date
    October 27, 2020
  • Phase
    Phase 3
  • Study Type
    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 - 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: 415-640-2322

Email: Angelica.Craighead@cgoncology.com

LOCATION

Facility Status Contact
Facility: Urology Centers of Alabama
Homewood, Alabama 35209
United States
Status: Recruiting Contact: Contact
Stacey Morgan
855-776-0015
Facility: BCG Oncology
Phoenix, Arizona 85032
United States
Status: Recruiting Contact: Principal Investigator
Eric Brewer, MD
424-212-4593
Facility: Mayo Clinic Cancer Center
Phoenix, Arizona 85054
United States
Status: Recruiting Contact: Contact
Debbi Mobley
424-212-4593
Facility: Arizona Institute of Urology
Tucson, Arizona 85704
United States
Status: Recruiting Contact: Principal Investigator
Donald Lamm, MD

Facility: American Institute of Research
Los Angeles, California 90017
United States
Status: Recruiting Contact: Principal Investigator
Mark Tyson, MD

Facility: Skyline Urology - Sherman Oaks
Sherman Oaks, California 91411
United States
Status: Recruiting Contact: Contact
Crystal Palencia

Facility: Skyline Urology - Torrance
Torrance, California 90505
United States
Status: Recruiting Contact: Principal Investigator
Jay Page, MD

Facility: Mayo Clinic - Jacksonville
Jacksonville, Florida 32224
United States
Status: Recruiting Contact: Contact
Steven Bereta

Facility: Emory University
Atlanta, Georgia 30322
United States
Status: Recruiting Contact: Principal Investigator
Edward Uchio, MD

Facility: University of Kansas
Kansas City, Kansas 66160
United States
Status: Recruiting Contact: Contact
Joel Marie Barra

Facility: New Jersey Urology
Edison, New Jersey 08837
United States
Status: Recruiting Contact: Principal Investigator
John Kowalczyk, MD

Facility: Montefiore Medical Center
Bronx, New York 10461
United States
Status: Recruiting Contact: Contact
Research Department

Facility: University of Toledo
Toledo, Ohio 43614
United States
Status: Recruiting Contact: Principal Investigator
Lawrence Flechner, MD

Facility: University of Pennsylvania, Perelman School of Medicine
Philadelphia, Pennsylvania 19104
United States
Status: Recruiting Contact: Contact
Andrew Hendrix

Facility: Prisma Health
Greenville, South Carolina 29615
United States
Status: Recruiting Contact: Principal Investigator
Timothy Lyon, MD

Facility: Carolina Urologic Research Center
Myrtle Beach, South Carolina 29572
United States
Status: Recruiting Contact: Contact
Misaki Mason

Facility: Urology San Antonio, PA
San Antonio, Texas 78229
United States
Status: Recruiting Contact: Contact
Haleema Hameed

Facility: Nara Medical University Hospital
Kashihara, 10408
Japan
Status: Recruiting Contact: Principal Investigator
Alex Sankin, MD

Facility: Okayama University Hospital
Okayama, 50612
Japan
Status: Recruiting Contact: Contact
Audrey Anderson

Facility: Osaka City University Hospital
Osaka, 58128
Japan
Status: Recruiting Contact: Principal Investigator
David Golumbos, MD

Facility: Osaka Medical and Pharmaceutical University Hospital
Osaka, 03080
Japan
Status: Recruiting Contact: Contact
Whitney Franz

Facility: Kitsato University Hospital
Sagamihara, 204
Japan
Status: Recruiting Contact: Principal Investigator
Brant Inman, MD

Facility: Ehime University Hospital
Toon, 40447
Japan
Status: Recruiting Contact: Contact
Stephanie Smiddy

Facility: Pusan National University Hospital
Busan,
Korea, Republic of
Status: Recruiting Contact: Principal Investigator
Firas G Petros, MD

Facility: Pusan National University Yangsan Hospital
Gyeongsang,
Korea, Republic of
Status: Recruiting Contact: Principal Investigator
Thomas Guzzo, MD

Facility: Chonnam National University Hwasun Hospital
Jeongnam,
Korea, Republic of
Status: Recruiting Contact: Contact
Leesa Judd

Facility: Seoul National University Hospital
Seoul,
Korea, Republic of
Status: Recruiting Contact: Principal Investigator
Ryan Werntz, MD

Facility: Korea University Anam Hospital
Seoul,
Korea, Republic of
Status: Recruiting Contact: Contact
Ryan Sutton

Facility: Severance Hospital
Seoul,
Korea, Republic of
Status: Recruiting Contact: Principal Investigator
Neal Shore, MD

Facility: The Catholic University of Korea
Seoul,
Korea, Republic of
Status: Recruiting Contact: Contact
Pamela Steele

Facility: Keelung Chang Gung Memorial Hospital
Keelung,
Taiwan
Status: Recruiting Contact: Principal Investigator
Sam Chang, MD

Facility: China Medical University Hospital
Taichung,
Taiwan
Status: Recruiting Contact: Contact
Perla Ramirez

Facility: Taipei Veterans General Hospital
Taipei,
Taiwan
Status: Recruiting Contact: Principal Investigator
Seth Lerner, MD