A Phase 3 Study of CG0070 in Patients With Non-Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Bacillus-Calmette-Guerin (BCG) (BOND-003)

  • End date
    Jul 31, 2025
  • participants needed
  • sponsor
    CG Oncology, Inc.
Updated on 23 October 2022


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


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.

Condition Non Muscular Invasive Bladder Cancer
Treatment CG0070, n-dodecyl-B-D-maltoside
Clinical Study IdentifierNCT04452591
SponsorCG Oncology, Inc.
Last Modified on23 October 2022


Yes No Not Sure

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)
At least five of six doses of an initial induction course (adequate induction)
Ineligible for radical cystectomy or refusal of radical cystectomy
plus at least two of three doses of maintenance therapy, OR
At least five of six doses of an initial induction course (adequate induction)
Adequate organ function
plus at least two of six doses of a second induction course

Exclusion Criteria

Has known upper tract or prostatic urethra malignancy
Muscle invasive (T2 or higher stage) or locally advanced (T3/T4, any N) or metastatic
bladder cancer
Prior treatment with adenovirus-based cancer therapy
Clinically significant or active cardiac disease
Active autoimmune disease
Has systemic anti-cancer therapy, including investigational agents, within 4 weeks of
Immuno-deficient due to chronic steroid or other immunosuppressant use, HIV, or prior
organ transplant
Clear my responses

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