Study of Cretostimogene 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

This is a Phase 3, open-label, single arm trial designed to evaluate Cretostimogene
patients with NMIBC who have failed prior BCG therapy. Up to approximately 115 CIS
bladder cancer patients with or without HG Ta or HG T1 papillary disease will be enrolled
under the original protocol through Amendment 4, which will comprise Cohort C. Cohort C
is closed to enrollment.

Under Amendment 5-1, Cohort P was added to enroll up to 70 patients with HG Ta/T1
papillary bladder cancer.

Under Amendment 6, the target number of patients enrolled in Cohort P was increased to
75. Cohort P is open to enrollment

Cohort C and Cohort P will be analyzed and reported separately. Patients will have had to
fail prior BCG therapy which is defined as having persistent or recurrent disease within
12 months (Cohort C) or 6 months (Cohort P) following the completion of adequate BCG
therapy for HGUC

Objectives

Cohort C(All Countries) :

An open-label trial designed to evaluate Cretostimogene + DDM in patients with NMIBC who
have failed prior BCG therapy. Single treatment arm that enrolled 115 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.

Cohort P(Japan and the United States Only):

To determine the all-cause High Grade Event Free Survival (HG-EFS) of cretostimogene in
up to 75 patients with BCG-unresponsive HG Ta/T1 papillary disease without CIS.

BCG failure is defined as a persistent or recurrent disease within 6 months of completion
of adequate BCG therapy.

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