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

A Phase 3 Study of CG0070 in Patients With Non-Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Bacillus-Calmette-Guerin (BCG)

INTRODUCTION

  • Org Study ID: CG3002S
  • Secondary ID: N/A
  • NCT ID: NCT04452591
  • Sponsor: CG Oncology, Inc.

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.

  • Overall Status
    Recruiting
  • Start Date
    October 27, 2020
  • Phase
    Phase 3
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Complete response rate in patients with carcinoma in situ (with or without concomitant high-grade Ta or T1 papillary disease)

Primary Outcome 1 - Timeframe: 24 months

CONDITION

  • Non Muscular Invasive Bladder Cancer

ELIGIBILITY

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: James Burke, MD

Role: Principal Investigator

Affiliation: CG Oncology, Inc.

Overall Contact

Name: James Burke, MD

Phone: 516-456-1415

Email: joann.horn@CGoncology.com

LOCATION

Facility Status Contact

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