Bladder Cancer Clinical Trial

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

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

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Full 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.

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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):

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

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

Study is for people with:

Bladder Cancer

Phase:

Phase 3

Estimated Enrollment:

110

Study ID:

NCT04452591

Recruitment Status:

Recruiting

Sponsor:

CG Oncology, Inc.

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Study is for people with:

Bladder Cancer

Phase:

Phase 3

Estimated Enrollment:

110

Study ID:

NCT04452591

Recruitment Status:

Recruiting

Sponsor:


CG Oncology, Inc.

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