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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: 516-456-1415

Email: joann.horn@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 #66049
Facility: Mayo Clinic Cancer Center
Phoenix, Arizona 85054
United States
Status: Recruiting Contact: Contact
Clinical Trials Office All Mayo Clinic Locations
+81-4-7133-1111
Facility: Arizona Institute of Urology
Tucson, Arizona 85704
United States
Status: Recruiting Contact: Principal Investigator
Mark Tyson, MD
+81-3-5363-3962
Facility: University of California - Irvine
Irvine, California 92868
United States
Status: Recruiting Contact: Contact
Crystal Palencia
+81-76-434-7863
Facility: Skyline Urology - Torrance
Torrance, California 90505
United States
Status: Recruiting Contact: Principal Investigator
Edward Uchio, MD

Facility: University of Colorado
Aurora, Colorado 80045
United States
Status: Recruiting Contact: Contact
Research Department

Facility: MedStar Hospital
Washington, District of Columbia 20010
United States
Status: Recruiting Contact: Principal Investigator
Lawrence Flechner, MD

Facility: Mayo Clinic - Jacksonville
Jacksonville, Florida 32224
United States
Status: Recruiting Contact: Contact
Janet Kukreja

Facility: Emory University
Atlanta, Georgia 30322
United States
Status: Recruiting Contact: Contact
Lambros Stamatakis

Facility: University of Kansas
Kansas City, Kansas 66160
United States
Status: Recruiting Contact: Contact
Andrew Hendrix

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

Facility: Montefiore Medical Center
Bronx, New York 10461
United States
Status: Recruiting Contact: Contact
Misaki Mason

Facility: StonyBrook Cancer Center
Stony Brook, New York 11794-263
United States
Status: Recruiting Contact: Principal Investigator
Shreyas Joshi, MD

Facility: Duke University
Durham, North Carolina 27710
United States
Status: Recruiting Contact: Principal Investigator
Eugene Lee, MD

Facility: University of Toledo
Toledo, Ohio 43614
United States
Status: Recruiting Contact: Contact
Haleema Hameed

Facility: University of Pennsylvania, Perelman School of Medicine
Philadelphia, Pennsylvania 19104
United States
Status: Recruiting Contact: Principal Investigator
Joshua Wein, MD

Facility: Prisma Health
Greenville, South Carolina 29615
United States
Status: Recruiting Contact: Contact
JoAnn Horn

Facility: Carolina Urologic Research Center
Myrtle Beach, South Carolina 29572
United States
Status: Recruiting Contact: Principal Investigator
Alex Sankin, MD

Facility: Baylor Scott and White
Houston, Texas 77030
United States
Status: Recruiting Contact: Principal Investigator
David Golumbos, MD

Facility: National Cancer Center Hospital East
Chiba, 10408
Japan
Status: Recruiting Contact: Contact
Stephanie Smiddy

Facility: Nagoya University Hospital
Fujita, 50612
Japan
Status: Recruiting Contact: Principal Investigator
Firas G Petros, MD

Facility: Chugoku Rosai Hospital
Hiroshima, 03080
Japan
Status: Recruiting Contact: Principal Investigator
Thomas Guzzo, MD

Facility: Shinshu University Hospital
Ishizuka, 204
Japan
Status: Recruiting Contact: Contact
Leesa Judd

Facility: University of Tsukuba Hospital
Kandori, 40447
Japan
Status: Recruiting Contact: Principal Investigator
Ryan Werntz, MD

Facility: Nara Medical University Hospital
Kashihara,
Japan
Status: Recruiting Contact: Contact
Ryan Sutton

Facility: St. Marianna University Hospital
Kikuchi,
Japan
Status: Recruiting Contact: Principal Investigator
Neal Shore, MD

Facility: Kagawa Rosai Hospital
Marugame,
Japan
Status: Recruiting Contact: Contact
Pamela Steele

Facility: Keio University Hospital
Matsumoto,
Japan
Status: Recruiting Contact: Principal Investigator
Sam Chang, MD

Facility: Okayama University Hospital
Okayama,
Japan
Status: Recruiting Contact: Contact
Perla Ramirez

Facility: Osaka City University Hospital
Osaka,
Japan
Status: Recruiting Contact: Principal Investigator
Belur Patel, MD

Facility: Osaka Medical and Pharmaceutical University Hospital
Osaka,
Japan
Status: Recruiting Contact: Contact
Joanne Broadrick

Facility: Kitsato University Hospital
Sagamihara,
Japan
Status: Recruiting Contact: Principal Investigator
Ali Tafreshi, MD

Facility: Saitama City Hospital
Saitama,
Japan
Status: Recruiting Contact: Contact
Dr. Hitoshi Masuda

Facility: Sapporo Medical University Hospital
Sapporo,
Japan
Status: Recruiting Contact: Contact
Dr. Kobayashi

Facility: Shizuoka General Hospital
Shizuoka,
Japan
Status: Recruiting Contact: Contact
Fujita

Facility: Keio University Hospital
Tokyo,
Japan
Status: Recruiting Contact: Contact
Masuda

Facility: Ehime University Hospital
Toon,
Japan
Status: Recruiting Contact: Contact
Dr. Naoya Masumori

Facility: Toyoma University Hospital
Toyoma,
Japan
Status: Recruiting Contact: Contact
Yoshimura

Facility: Wakayama Medical University Hospital
Wakayama,
Japan
Status: Recruiting Contact: Contact
Dr. Kazuhiro Mastumoto

Facility: Pusan National University Hospital
Busan,
Korea, Republic of
Status: Recruiting Contact: Contact
Dr. Naotaka Nishiyama

Facility: National Cancer Center
Goyang-si,
Korea, Republic of
Status: Recruiting Contact: Contact
Hara

Facility: Pusan National University Yangsan Hospital
Gyeongsang,
Korea, Republic of
Status: Recruiting Contact: Principal Investigator
Hong Koo Ha, MD

Facility: Chonnam National University Hwasun Hospital
Jeongnam,
Korea, Republic of
Status: Recruiting Contact: Contact
Ha Rim Han

Facility: Seoul National University Hospital
Seoul,
Korea, Republic of
Status: Recruiting Contact: Principal Investigator
Ho Kyung Seo, MD

Facility: Korea University Anam Hospital
Seoul,
Korea, Republic of
Status: Recruiting Contact: Contact
Yu Jin Jung

Facility: Severance Hospital
Seoul,
Korea, Republic of
Status: Recruiting Contact: Principal Investigator
Jong Kil Nam, MD

Facility: The Catholic University of Korea
Seoul,
Korea, Republic of
Status: Recruiting Contact: Contact
Mi Young Jung

Facility: Keelung Chang Gung Memorial Hospital
Keelung City,
Taiwan
Status: Recruiting Contact: Principal Investigator
Seung II Jung, MD

Facility: Keelung Chang Gung Memorial Hospital
Keelung,
Taiwan
Status: Recruiting Contact: Contact
Song Hee Kim

Facility: China Medical University Hospital
Taichung,
Taiwan
Status: Recruiting Contact: Principal Investigator
Ja Hyeon Ku, MD

Facility: National Taiwan University Hospital
Taipei,
Taiwan
Status: Recruiting Contact: Contact
Hong, MD

Facility: Taipei Veterans General Hospital
Taipei,
Taiwan
Status: Recruiting Contact: Contact
Chieh-Ping Wen