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

Active:	Yes
Cancer Type:	Bladder Cancer Unknown Primary	NCT ID:	NCT04452591
Trial Phases:	Phase III	Protocol IDs:	CG3002S (primary) NCI-2021-01691
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	CG Oncology, Inc.
NCI Full Details:	http://clinicaltrials.gov/show/NCT04452591

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

Objectives

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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