Clinical Trials /

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

NCT04452591

Description:

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

Related Conditions:
  • Bladder Urothelial Carcinoma In Situ
Recruiting Status:

Recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • 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)

Clinical Trial IDs

  • ORG STUDY ID: CG3002S
  • NCT ID: NCT04452591

Conditions

  • Non Muscular Invasive Bladder Cancer

Interventions

DrugSynonymsArms
CG0070Single Arm

Purpose

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.
    

Trial Arms

NameTypeDescriptionInterventions
Single ArmExperimentalPatients 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.
  • CG0070

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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Complete response rate in patients with carcinoma in situ (with or without concomitant high-grade Ta or T1 papillary disease)
Time Frame:24 months
Safety Issue:
Description:Percentage of patients with a complete response as defined by FDA guidance document dated February 2018 for NMIBC.

Secondary Outcome Measures

Measure:Median Duration of response (DOR)
Time Frame:24 months
Safety Issue:
Description:Median duration of response in patients with a CR or PR in subjects
Measure:Median progression free survival
Time Frame:24 months
Safety Issue:
Description:Median duration of progression free survival of subjects
Measure:Time to tumor progression (TTP)
Time Frame:24 months
Safety Issue:
Description:Median time until patient disease progression (PD) in subjects
Measure:Incidence of adverse events when CG0070 administered alone.
Time Frame:24 months
Safety Issue:
Description:Percentage of patients with adverse events by grade as determined by NCI CTCAE v5.0.
Measure:Comparison of complete response in patients with persistent disease versus relapsed disease at baseline.
Time Frame:24 months
Safety Issue:
Description:Percentage in CR

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:CG Oncology, Inc.

Trial Keywords

  • high-grade Ta papillary disease
  • high-grade T1 papillary disease
  • carcinoma in situ
  • Bacillus-Calmette-Guerin unresponsive

Last Updated

April 9, 2021