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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04452591
Recruitment Status : Recruiting
First Posted : June 30, 2020
Last Update Posted : May 12, 2023
Sponsor:
Information provided by (Responsible Party):
CG Oncology, Inc.

Study Description
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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
Non Muscular Invasive Bladder Cancer 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
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : October 27, 2020
Estimated Primary Completion Date : January 31, 2024
Estimated Study Completion Date : July 31, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer

Arms and Interventions
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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 Name: DDM


Outcome Measures
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Primary Outcome Measures :
  1. Complete response rate in patients with carcinoma in situ (with or without concomitant high-grade Ta or T1 papillary disease) [ Time Frame: 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) [ Time Frame: 24 months ]
    Median duration of response in patients with a CR or PR in subjects

  2. Median progression free survival [ Time Frame: 24 months ]
    Median duration of progression free survival of subjects

  3. Time to tumor progression (TTP) [ Time Frame: 24 months ]
    Median time until patient disease progression (PD) in subjects

  4. Incidence of adverse events when CG0070 administered alone. [ Time Frame: 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. [ Time Frame: 24 months ]
    Percentage in CR


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04452591


Contacts
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Contact: JoAnn Horn 516-456-1415 joann.horn@CGoncology.com

Locations
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Sponsors and Collaborators
CG Oncology, Inc.
Investigators
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Principal Investigator: James Burke, MD CG Oncology, Inc.
More Information
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Responsible Party: CG Oncology, Inc.
ClinicalTrials.gov Identifier: NCT04452591    
Other Study ID Numbers: CG3002S
First Posted: June 30, 2020    Key Record Dates
Last Update Posted: May 12, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Urinary Bladder Neoplasms
Non-Muscle Invasive Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
 Urogenital Diseases
Urinary Bladder Diseases
Urologic Diseases
Male Urogenital Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type