Study of CG0070 Given in Patients With Non-Muscle Invasive Bladder Cancer ,Unresponsive to Bacillus-Calmette-Guerin (BOND-003)

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

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

Study Overview

• Status: Recruiting
• Conditions: Non Muscular Invasive Bladder Cancer
• Intervention / Treatment: Biological: CG0070; Other: n-dodecyl-B-D-maltoside

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.

• Study Type: Interventional
• Enrollment (Anticipated): 110
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: JoAnn Horn; Phone Number: 516-456-1415; Email: joann.horn@CGoncology.com

Study Locations

• Australia
  • Geelong, Australia
    • Active, not recruiting
    • Barwon Health, University Hospital Geelong
  • Melbourne, Australia
    • Active, not recruiting
    • Royal Melbourne Hospital
  • Wollongong, Australia
    • Active, not recruiting
    • Wollongong Private Hospital
• Japan
  • Chiba, Japan
    • Active, not recruiting
    • National Cancer Center Hospital East
  • Fujita, Japan
    • Active, not recruiting
    • Nagoya University Hospital
  • Hashimoto, Japan
    • Active, not recruiting
    • Hirosaki University Hospital
  • Hiroshima, Japan
    • Active, not recruiting
    • Chugoku Rosai Hospital
  • Ishizuka, Japan
    • Active, not recruiting
    • Shinshu University Hospital
  • Kandori, Japan
    • Active, not recruiting
    • University of Tsukuba Hospital
  • Kashihara, Japan
    • Active, not recruiting
    • Nara Medical University Hospital
  • Kashiwa, Japan
    • Active, not recruiting
    • The Jikei University Kashiwa Hospital
  • Kikuchi, Japan
    • Active, not recruiting
    • St. Marianna University Hospital
  • Kyoto, Japan
    • Active, not recruiting
    • National Hospital Organization Kyoto Medical Center
  • Marugame, Japan
    • Active, not recruiting
    • Kagawa Rosai Hospital
  • Matsumoto, Japan
    • Active, not recruiting
    • Keio University Hospital
  • Okayama, Japan
    • Active, not recruiting
    • Okayama University Hospital
  • Osaka, Japan
    • Active, not recruiting
    • Osaka City University Hospital
  • Osaka, Japan
    • Active, not recruiting
    • Osaka Medical and Pharmaceutical University Hospital
  • Sagamihara, Japan
    • Active, not recruiting
    • Kitsato University Hospital
  • Saitama, Japan
    • Active, not recruiting
    • Saitama City Hospital
  • Sapporo, Japan
    • Active, not recruiting
    • Sapporo Medical University Hospital
  • Shizuoka, Japan
    • Active, not recruiting
    • Shizuoka General Hospital
  • Tokyo, Japan
    • Active, not recruiting
    • Keio University Hospital
  • Toon, Japan
    • Active, not recruiting
    • Ehime University Hospital
  • Toyoma, Japan
    • Active, not recruiting
    • Toyoma University Hospital
  • Wakayama, Japan
    • Active, not recruiting
    • Wakayama Medical University Hospital
  • Yokohama, Japan
    • Active, not recruiting
    • National Hospital Organization Yokohama Medical Center
• Korea, Republic of
  • Busan, Korea, Republic of, 49241
    • Active, not recruiting
    • Pusan National University Hospital
  • Goyang-si, Korea, Republic of, 10408
    • Active, not recruiting
    • National Cancer Center
  • Gyeongsang, Korea, Republic of, 50612
    • Active, not recruiting
    • Pusan National University Yangsan Hospital
  • Jeongnam, Korea, Republic of, 58128
    • Active, not recruiting
    • Chonnam National University Hwasun Hospital
  • Seoul, Korea, Republic of, 03080
    • Active, not recruiting
    • Seoul National University Hospital
  • Seoul, Korea, Republic of
    • Active, not recruiting
    • Severance Hospital
  • Seoul, Korea, Republic of
    • Active, not recruiting
    • Korea University Anam Hospital
  • Seoul, Korea, Republic of
    • Active, not recruiting
    • The Catholic University of Korea
• Taiwan
  • Keelung, Taiwan, 204
    • Active, not recruiting
    • Keelung Chang Gung Memorial Hospital
  • Keelung City, Taiwan
    • Active, not recruiting
    • Keelung Chang Gung Memorial Hospital
  • Taichung, Taiwan, 40447
    • Active, not recruiting
    • China Medical University Hospital
  • Taipei, Taiwan
    • Active, not recruiting
    • National Taiwan University Hospital
  • Taipei, Taiwan
    • Active, not recruiting
    • Taipei Veterans General Hospital
• United States
  • Alabama
    • Homewood, Alabama, United States, 35209
      • Active, not recruiting
      • Urology Centers Of Alabama
  • Arizona
    • Phoenix, Arizona, United States, 85054
      • Recruiting
      • Mayo Clinic Cancer Center
      • Contact: Clinical Trials Office All Mayo Clinic Locations; Phone Number: 855-776-0015
      • Principal Investigator: Mark Tyson, MD
    • Phoenix, Arizona, United States, 85032
      • Active, not recruiting
      • BCG Oncology
    • Tucson, Arizona, United States, 85704
      • Recruiting
      • Arizona Institute of Urology
      • Contact: Crystal Palencia
      • Principal Investigator: Jay Page, MD
  • California
    • Irvine, California, United States, 92868
      • Recruiting
      • University of California - Irvine
      • Contact: Steven Bereta
      • Principal Investigator: Edward Uchio, MD
    • Los Angeles, California, United States, 90017
      • Active, not recruiting
      • American Institute of Research
    • Sherman Oaks, California, United States, 91411
      • Active, not recruiting
      • Skyline Urology - Sherman Oaks
    • Torrance, California, United States, 90505
      • Active, not recruiting
      • Skyline Urology - Torrance
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Recruiting
      • University of Colorado
      • Contact: Janet Kukreja
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • Recruiting
      • MedStar Hospital
      • Contact: Lambros Stamatakis
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Recruiting
      • Mayo Clinic - Jacksonville
      • Contact: Andrew Hendrix
      • Principal Investigator: Timothy Lyon, MD
    • Tampa, Florida, United States, 33612
      • Recruiting
      • Moffit Cancer Center
      • Contact: Rodger Li
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Recruiting
      • Emory University
      • Contact: Misaki Mason
      • Principal Investigator: Shreyas Joshi, MD
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • Recruiting
      • University of Kansas
      • Principal Investigator: Eugene Lee, MD
  • Maryland
    • Severna Park, Maryland, United States, 21076
      • Recruiting
      • Chesapeake Urology
      • Contact: Rian Dickstein
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Rochester
      • Contact: Paras Shah
  • Missouri
    • Saint Louis, Missouri, United States, 63109
      • Recruiting
      • Mercy Medical Center
      • Contact: Gautam Agarwal
  • New Jersey
    • Edison, New Jersey, United States, 08837
      • Recruiting
      • New Jersey Urology
      • Contact: Haleema Hameed
      • Principal Investigator: Joshua Wein, MD
  • New York
    • Binghamton, New York, United States, 13905
      • Recruiting
      • Our Lady of Lourdes
      • Contact: Kathleen McGinley
    • Bronx, New York, United States, 10461
      • Active, not recruiting
      • Montefiore Medical Center
    • Stony Brook, New York, United States, 11794-263
      • Recruiting
      • StonyBrook Cancer Center
      • Contact: Audrey Anderson
      • Principal Investigator: David Golumbos, MD
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Recruiting
      • Duke University
      • Contact: Whitney Franz
      • Principal Investigator: Brant Inman, MD
    • Winston-Salem, North Carolina, United States, 27109
      • Recruiting
      • Wake Forest University
      • Contact: Matvey Tsivian
  • Ohio
    • Toledo, Ohio, United States, 43614
      • Recruiting
      • University of Toledo
      • Contact: Stephanie Smiddy
      • Principal Investigator: Firas G Petros, MD
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • University of Pennsylvania, Perelman School of Medicine
      • Contact: Hanna Stambakio
      • Principal Investigator: Thomas Guzzo, MD
  • South Carolina
    • Greenville, South Carolina, United States, 29615
      • Recruiting
      • Prisma Health
      • Contact: Leesa Judd
      • Principal Investigator: Ryan Werntz, MD
    • Myrtle Beach, South Carolina, United States, 29572
      • Recruiting
      • Carolina Urologic Research Center
      • Contact: Ryan Sutton
      • Principal Investigator: Neal Shore, MD
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Recruiting
      • Vanderbilt University Medical Center
      • Contact: Pamela Steele
      • Principal Investigator: Sam Chang, MD
  • Texas
    • Houston, Texas, United States, 77030
      • Active, not recruiting
      • Baylor Scott and White
    • San Antonio, Texas, United States, 78229
      • Withdrawn
      • Urology San Antonio, PA
  • Washington
    • Spokane, Washington, United States, 99202
      • Active, not recruiting
      • Spokane Urology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete response rate in patients with carcinoma in situ (with or without concomitant high-grade Ta or T1 papillary disease)	Percentage of patients with a complete response as defined by FDA guidance document dated February 2018 for NMIBC.	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Median Duration of response (DOR)	Median duration of response in patients with a CR or PR in subjects	24 months
Median progression free survival	Median duration of progression free survival of subjects	24 months
Time to tumor progression (TTP)	Median time until patient disease progression (PD) in subjects	24 months
Incidence of adverse events when CG0070 administered alone.	Percentage of patients with adverse events by grade as determined by NCI CTCAE v5.0.	24 months
Comparison of complete response in patients with persistent disease versus relapsed disease at baseline.	Percentage in CR	24 months

Collaborators and Investigators

• Sponsor: CG Oncology, Inc.
• Investigators: Principal Investigator: James Burke, MD, CG Oncology, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): October 27, 2020
• Primary Completion (Anticipated): January 31, 2024
• Study Completion (Anticipated): July 31, 2025

Study Registration Dates

• First Submitted: June 26, 2020
• First Submitted That Met QC Criteria: June 29, 2020
• First Posted (Actual): June 30, 2020

Study Record Updates

• Last Update Posted (Actual): May 12, 2023
• Last Update Submitted That Met QC Criteria: May 10, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: high-grade Ta papillary disease; high-grade T1 papillary disease; carcinoma in situ; Bacillus-Calmette-Guerin unresponsive
• Additional Relevant MeSH Terms: Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urologic Diseases; Urinary Bladder Diseases; Urinary Bladder Neoplasms
• Other Study ID Numbers: CG3002S

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No