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

Phase 2

Recruiting

• Conditions: High-Risk Non-Muscle-Invasive Bladder Cancer
• Interventions: Drug: Cretostimogene Grenadenorepvec; Drug: n-dodecyl-B-D-maltoside

• Registration Number: NCT06567743
• Lead Sponsor: CG Oncology, Inc.

Brief Summary

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.

Detailed Description

In Cohort A, up to 50 participants will be enrolled with pathologically confirmed, CIS-containing, high-risk NMIBC (i.e., CIS with or without concomitant Ta/T1) who are naïve to BCG treatment. Participants will be randomized 1:1 to receive DDM and cretostimogene via the current (Arm 1) or an alternative instillation procedure (Arm 2).

Cretostimogene and DDM will be administered as a weekly induction course for the first 6 weeks with a reinduction course administered to patients who have CIS and/or high-grade Ta disease at the 3-month evaluation. Following induction, if no high-grade disease is detected, maintenance treatment will begin. This consists of a cycle of three weekly treatments every three months during the first year, and every six months during the second year, with an optional extension to the third year following the same six-month schedule.

Disease status will be assessed using urine cytology, complete bladder visualization (e.g., cystoscopy), upper tract assessment and and directed TURBT/biopsy (if indicated) every 3 months for the first 2 years after randomization and then every 6 months for a further 2 years or until disease recurrence.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2024-08-14
• Study First Submitted QC: 2024-08-20
• Study First Posted: 2024-08-23
• Study Start: 2024-09-16
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-03
• Last Update Posted: 2024-10-07
• Primary Completion: 2027-03-31
• Study Completion: 2027-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion 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.

Key

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Exclusion Criteria

• 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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental: Cohort A, Arm 1	Cretostimogene Grenadenorepvec	Cretostimogene (1 x 1012 vp) and DDM (0.1%) will be administered intravesically via the current instillation method
Experimental: Cohort A, Arm 1	n-dodecyl-B-D-maltoside	Cretostimogene (1 x 1012 vp) and DDM (0.1%) will be administered intravesically via the current instillation method
Experimental: Cohort A, Arm 2	Cretostimogene Grenadenorepvec	Cretostimogene (1 x 1012 vp) and DDM (0.1%) will be administered intravesically via an alternative instillation method.
Experimental: Cohort A, Arm 2	n-dodecyl-B-D-maltoside	Cretostimogene (1 x 1012 vp) and DDM (0.1%) will be administered intravesically via an alternative instillation method.

Primary Outcome Measures

Name	Time	Method
Cohort A: Complete response rate	At 11 and 24 weeks	Determine the complete response rate at any time following treatment with cretostimogene in participants with Bacillus Calmette-Guerin (BCG)-naïve carcinoma in situ (CIS) with or without concomitant high-grade (HG) Ta or T1 disease at baseline

Secondary Outcome Measures

Name	Time	Method
Compare cretostimogene instillation methods	At 12 and 24 weeks	Compare cretostimogene genome and GM-CSF levels, treatment efficacy, and safety by 2 different methods of cretostimogene instillation in participants with pathologically confirmed CIS-containing high-risk NMIBC who are naïve to BCG treatment.
Duration of response (DoR)	At 12 and 24 weeks	Assess duration of response (DoR) in participants with CIS with or without concomitant HG Ta/T1 disease at baseline

Trial Locations

Locations (3)

Southern Urology (Urology America); 🇺🇸 Lafayette, Louisiana, United States

The Conrad Pearson Clinic (Urology America); 🇺🇸 Germantown, Tennessee, United States

Urology Austin, PLLC (Urology America); 🇺🇸 Austin, Texas, United States