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

Sponsor
CG Oncology, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04452591
Collaborator
(none)
110
Enrollment
59
Locations
1
Arm
49.1
Anticipated Duration (Months)
1.9
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Biological: CG0070
  • Other: n-dodecyl-B-D-maltoside
 Phase 3

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 Design

Study Type:
Interventional
Anticipated Enrollment :
110 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 3 Study of CG0070 in Patients With Non-Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Bacillus-Calmette-Guerin (BCG)
Actual Study Start Date :
Oct 27, 2020
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Complete response rate in patients with carcinoma in situ (with or without concomitant high-grade Ta or T1 papillary disease) [24 months]

      Percentage of patients with a complete response as defined by FDA guidance document dated February 2018 for NMIBC.

    Secondary Outcome Measures

    1. Median Duration of response (DOR) [24 months]

      Median duration of response in patients with a CR or PR in subjects

    2. Median progression free survival [24 months]

      Median duration of progression free survival of subjects

    3. Time to tumor progression (TTP) [24 months]

      Median time until patient disease progression (PD) in subjects

    4. Incidence of adverse events when CG0070 administered alone. [24 months]

      Percentage of patients with adverse events by grade as determined by NCI CTCAE v5.0.

    5. Comparison of complete response in patients with persistent disease versus relapsed disease at baseline. [24 months]

      Percentage in CR

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Urology Centers of Alabama Homewood Alabama United States 35209
    2 BCG Oncology Phoenix Arizona United States 85032
    3 Mayo Clinic Cancer Center Phoenix Arizona United States 85054
    4 Arizona Institute of Urology Tucson Arizona United States 85704
    5 University of California - Irvine Irvine California United States 92868
    6 American Institute of Research Los Angeles California United States 90017
    7 Skyline Urology - Sherman Oaks Sherman Oaks California United States 91411
    8 Skyline Urology - Torrance Torrance California United States 90505
    9 University of Colorado Aurora Colorado United States 80045
    10 MedStar Hospital Washington District of Columbia United States 20010
    11 Mayo Clinic - Jacksonville Jacksonville Florida United States 32224
    12 Emory University Atlanta Georgia United States 30322
    13 University of Kansas Kansas City Kansas United States 66160
    14 New Jersey Urology Edison New Jersey United States 08837
    15 Montefiore Medical Center Bronx New York United States 10461
    16 StonyBrook Cancer Center Stony Brook New York United States 11794-263
    17 Duke University Durham North Carolina United States 27710
    18 University of Toledo Toledo Ohio United States 43614
    19 University of Pennsylvania, Perelman School of Medicine Philadelphia Pennsylvania United States 19104
    20 Prisma Health Greenville South Carolina United States 29615
    21 Carolina Urologic Research Center Myrtle Beach South Carolina United States 29572
    22 Vanderbilt University Medical Center Nashville Tennessee United States 37232
    23 Baylor Scott and White Houston Texas United States 77030
    24 Urology San Antonio, PA San Antonio Texas United States 78229
    25 Wollongong Private Hospital Wollongong Australia
    26 National Cancer Center Hospital East Chiba Japan
    27 Nagoya University Hospital Fujita Japan
    28 Hirosaki University Hospital Hashimoto Japan
    29 Chugoku Rosai Hospital Hiroshima Japan
    30 Shinshu University Hospital Ishizuka Japan
    31 University of Tsukuba Hospital Kandori Japan
    32 Nara Medical University Hospital Kashihara Japan
    33 St. Marianna University Hospital Kikuchi Japan
    34 Kagawa Rosai Hospital Marugame Japan
    35 Keio University Hospital Matsumoto Japan
    36 Okayama University Hospital Okayama Japan
    37 Osaka City University Hospital Osaka Japan
    38 Osaka Medical and Pharmaceutical University Hospital Osaka Japan
    39 Kitsato University Hospital Sagamihara Japan
    40 Saitama City Hospital Saitama Japan
    41 Sapporo Medical University Hospital Sapporo Japan
    42 Shizuoka General Hospital Shizuoka Japan
    43 Keio University Hospital Tokyo Japan
    44 Ehime University Hospital Toon Japan
    45 Toyoma University Hospital Toyoma Japan
    46 Wakayama Medical University Hospital Wakayama Japan
    47 Pusan National University Hospital Busan Korea, Republic of 49241
    48 National Cancer Center Goyang-si Korea, Republic of 10408
    49 Pusan National University Yangsan Hospital Gyeongsang Korea, Republic of 50612
    50 Chonnam National University Hwasun Hospital Jeongnam Korea, Republic of 58128
    51 Seoul National University Hospital Seoul Korea, Republic of 03080
    52 Korea University Anam Hospital Seoul Korea, Republic of
    53 Severance Hospital Seoul Korea, Republic of
    54 The Catholic University of Korea Seoul Korea, Republic of
    55 Keelung Chang Gung Memorial Hospital Keelung City Taiwan
    56 Keelung Chang Gung Memorial Hospital Keelung Taiwan 204
    57 China Medical University Hospital Taichung Taiwan 40447
    58 National Taiwan University Hospital Taipei Taiwan
    59 Taipei Veterans General Hospital Taipei Taiwan

    Sponsors and Collaborators

    • CG Oncology, Inc.

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    CG Oncology, Inc.
    ClinicalTrials.gov Identifier:
    NCT04452591
    Other Study ID Numbers:
    • CG3002S
    First Posted:
    Jun 30, 2020
    Last Update Posted:
    Jun 21, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by CG Oncology, Inc.
    high-grade Ta papillary disease
    high-grade T1 papillary disease
    carcinoma in situ
    Bacillus-Calmette-Guerin unresponsive
    Additional relevant MeSH terms:
    Urinary Bladder Neoplasms

    Study Results

    No Results Posted as of Jun 21, 2022