Study of CG0070 Given in Patients With Non-Muscular Invasive Bladder Cancer ,Unresponsive to Bacillus-Calmette-Guerin

Overview

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

Full Title of Study: “A Phase 3 Study of CG0070 in Patients With Non-Muscular Invasive Bladder Cancer (NMIBC) Unresponsive to Bacillus-Calmette-Guerin (BCG)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2022

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.

Interventions

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

Arms, Groups and Cohorts

  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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

Participating in This Clinical Trial

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)13 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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • CG Oncology, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • James Burke, MD, Principal Investigator, CG Oncology, Inc.
  • Overall Contact(s)
    • Stephanie Harris, 9494093700, stephanie.harris@cgoncology.com

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