Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Irvine, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Edward Uchio, MD

Description

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

Official Title

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

Details

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.

Keywords

Non Muscular Invasive Bladder Cancer high-grade Ta papillary disease high-grade T1 papillary disease carcinoma in situ Bacillus-Calmette-Guerin unresponsive Urinary Bladder Neoplasms n-dodecyl-B-D-maltoside

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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):
  • At least five of six doses of an initial induction course (adequate induction) plus at least two of three doses of maintenance therapy, OR
  • 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

You CAN'T join if...

  • 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

Locations

  • University of California - Irvine not yet accepting patients
    Irvine California 92868 United States
  • Skyline Urology - Torrance accepting new patients
    Torrance California 90505 United States

Lead Scientist at UC Irvine

  • Edward Uchio, MD
    Clinical Professor, Urology. Authored (or co-authored) 58 research publications.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
CG Oncology, Inc.
ID
NCT04452591
Phase
Phase 3
Study Type
Interventional
Last Updated