Brief Title: Phase 2 Study to Evaluate Safety and Efficacy of Cretostimogene Grenadenorepvec in High-Risk NMIBC

Description

This is a Phase 2, Multi-Arm, Multi-Cohort, Open-Label Study to Evaluate the Safety and Efficacy of Cretostimogene Grenadenorepvec in Participants with High-Risk Non-Muscle-Invasive Bladder Cancer.

Conditions

High-Risk Non-Muscle-Invasive Bladder Cancer

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Study Overview

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Study Details

Study overview

This is a Phase 2, Multi-Arm, Multi-Cohort, Open-Label Study to Evaluate the Safety and Efficacy of Cretostimogene Grenadenorepvec in Participants with High-Risk Non-Muscle-Invasive Bladder Cancer.

A Phase 2, Multi-Arm, Multi-Cohort, Open-Label Study to Evaluate the Safety and Efficacy of Cretostimogene Grenadenorepvec in Participants With High-Risk Non-Muscle-Invasive Bladder Cancer (NMIBC)

Brief Title: Phase 2 Study to Evaluate Safety and Efficacy of Cretostimogene Grenadenorepvec in High-Risk NMIBC

Condition
High-Risk Non-Muscle-Invasive Bladder Cancer
Intervention / Treatment

-

Contacts and Locations

Lafayette

Southern Urology (Urology America), Lafayette, Louisiana, United States, 70508

Germantown

The Conrad Pearson Clinic (Urology America), Germantown, Tennessee, United States, 38138

Austin

Urology Austin, PLLC (Urology America), Austin, Texas, United States, 78745

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Pathologically confirmed BCG-naïve, CIS-containing (i.e., CIS with or without concomitant HG Ta/T1) high-risk NMIBC within 90 days of randomization.
  • * Participants with BCG-naïve NMIBC should have either:
  • * No prior treatment with BCG OR
  • * No treatment with BCG within the past 24 months prior to current pathological diagnosis OR
  • * A maximum of 1 or 2 doses of BCG within the past 24 months prior to current pathological diagnosis.
  • * All visible disease must be resected, and all CIS resected or fulgurated, as feasible within 90 days prior to randomization.
  • * Acceptable baseline organ function.
  • * Current or past history of muscle-invasive, locally advanced or metastatic bladder cancer.
  • * High-grade disease in the upper urinary tract or prostatic urethra within 24 months of randomization or any history of muscle-invasive, locally advanced or metastatic disease in the upper urinary tract.
  • * Significant immunodeficiency.
  • * Pregnant or breastfeeding.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

CG Oncology, Inc.,

Pat Keegan, STUDY_DIRECTOR, CG Oncology

Study Record Dates

2027-12-30