Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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 : August 27, 2021
Sponsor:
Information provided by (Responsible Party):
CG Oncology, Inc.

Tracking Information
First Submitted Date  ICMJE June 26, 2020
First Posted Date  ICMJE June 30, 2020
Last Update Posted Date August 27, 2021
Actual Study Start Date  ICMJE October 27, 2020
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 29, 2020)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 29, 2020)
  • Median Duration of response (DOR) [ Time Frame: 24 months ]
    Median duration of response in patients with a CR or PR in subjects
  • Median progression free survival [ Time Frame: 24 months ]
    Median duration of progression free survival of subjects
  • Time to tumor progression (TTP) [ Time Frame: 24 months ]
    Median time until patient disease progression (PD) in subjects
  • 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.
  • Comparison of complete response in patients with persistent disease versus relapsed disease at baseline. [ Time Frame: 24 months ]
    Percentage in CR
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of CG0070 Given in Patients With Non-Muscle Invasive Bladder Cancer ,Unresponsive to Bacillus-Calmette-Guerin
Official Title  ICMJE A Phase 3 Study of CG0070 in Patients With Non-Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Bacillus-Calmette-Guerin (BCG)
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Non Muscular Invasive Bladder Cancer
Intervention  ICMJE
  • Biological: CG0070
    Engineered Oncolytic Adenovirus
  • Other: n-dodecyl-B-D-maltoside
    Transduction-enhancing agent.
    Other Name: DDM
Study Arms  ICMJE 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.

Interventions:
  • Biological: CG0070
  • Other: n-dodecyl-B-D-maltoside
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 29, 2020)
110
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2024
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Angelica Craighead 415-640-2322 Angelica.Craighead@cgoncology.com
Listed Location Countries  ICMJE Australia,   Japan,   Korea, Republic of,   Taiwan,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04452591
Other Study ID Numbers  ICMJE CG3002S
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party CG Oncology, Inc.
Study Sponsor  ICMJE CG Oncology, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: James Burke, MD CG Oncology, Inc.
PRS Account CG Oncology, Inc.
Verification Date August 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP