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

NCT04452591 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 190

Last updated 2026-03-16

No results posted yet for this study

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

Conditions

  • Non Muscle Invasive Bladder Cancer
  • High-grade Ta/ T1 Papillary Disease Bladder Cancer

Interventions

BIOLOGICAL

Cretostimogene Grenadenorepvec

Engineered Oncolytic Adenovirus

OTHER

n-dodecyl-B-D-maltoside

Transduction-enhancing agent.

Sponsors & Collaborators

  • CG Oncology, Inc.

    lead INDUSTRY

Principal Investigators

  • CG Oncology · CG Oncology

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-27
Primary Completion
2030-06-16
Completion
2031-12-24
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada
  • Japan
  • South Korea
  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04452591 on ClinicalTrials.gov