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

• ClinicalTrials.gov Identifier: NCT04452591
• Recruitment Status: Recruiting
• First Posted: June 30, 2020
• Last Update Posted: May 12, 2023
• Sponsor: CG Oncology, Inc.
• Information provided by (Responsible Party): CG Oncology, Inc.

Tracking Information

• First Submitted Date: June 26, 2020
• First Posted Date: June 30, 2020
• Last Update Posted Date: May 12, 2023
• Actual Study Start Date: October 27, 2020
• Estimated Primary Completion Date: January 31, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Study of CG0070 Given in Patients With Non-Muscle Invasive Bladder Cancer ,Unresponsive to Bacillus-Calmette-Guerin
• Official Title: 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: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Non Muscular Invasive Bladder Cancer

Intervention

• Biological: CG0070
  Engineered Oncolytic Adenovirus
• Other: n-dodecyl-B-D-maltoside
  Transduction-enhancing agent.
  Other Name: DDM

Study Arms

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

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: June 29, 2020): 110
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: July 31, 2025
• Estimated Primary Completion Date: January 31, 2024 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

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

• Listed Location Countries: Australia, Japan, Korea, Republic of, Taiwan, United States

Administrative Information

• NCT Number: NCT04452591
• Other Study ID Numbers: 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

• Plan to Share IPD: No

• Current Responsible Party: CG Oncology, Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: CG Oncology, Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: CG Oncology, Inc.
• Verification Date: May 2023