NCT06567743|RecruitingPhase 2DMCFDA Drug

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

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)

CG Oncology, Inc.ClinicalTrials.gov

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1 other identifier

CORE-008

Study Type

interventional

Target

325

Locations

1 country

Sites

Timeline

RegisteredAug 2024

StartedSep 2024

CompletionDec 2027

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

325

participants targeted

Target at P75+ for phase_2

Timeline

20mo left

Started Sep 2024

Typical duration for phase_2

Geographic Reach

1 country

65 active sites

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

3.3 years study duration

Study Progress50%

Sep 2024Dec 2027

First Submitted

Initial submission to the registry

August 14, 2024

Completed

9 days until next milestone

First Posted

Study publicly available on registry

August 23, 2024

Completed

24 days until next milestone

Study Start

First participant enrolled

September 16, 2024

Completed

2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2027

Expected

9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2027

Last Updated

April 8, 2026

Status Verified

April 1, 2026

Enrollment Period

2.5 years

First QC Date

August 14, 2024

Last Update Submit

April 6, 2026

Conditions

High-Risk Non-Muscle-Invasive Bladder Cancer

Keywords

Bladder Cancer

Outcome Measures

Primary Outcomes (6)

Cohort A (Arm 1 and 2): Complete response rate
Determine the complete response rate at any time following treatment with cretostimogene in participants with BCG-naïve CIS with or without concomitant high-grade Ta or T1 disease at baseline
At 11 and 24 weeks
Cohort A (Arm 3): High- Grade Event-Free Survival
Determine the High-Grade Event-Free Survival following treatment with cretostimogene in participants with BCG-naïve HG Ta/T1 disease without concomitant CIS at baseline.
48 months
Cohort B (Arm 1): Complete response rate
Determine the complete response rate at any time following treatment with cretostimogene in participants with BCG-exposed CIS with or without concomitant high-grade Ta or T1 disease at baseline.
At 11 and 24 weeks
Cohort B (Arm 2): High-Grade Event-Free Survival
Determine the High-Grade Event-Free Survival following treatment with cretostimogene in participants with BCG-exposed high-grade Ta/T1 papillary disease without CIS at baseline.
48 months
Cohort CX (Arms 1 and 2): High-Grade Event-Free Survival
Determine the High-Grade Event-Free Survival following treatment with cretostimogene in participants with BCG-exposed or BCG-unresponsive high-grade NMIBC.
48 months
Cohort CX (Arms 1 and 2): Safety
Determine the safety of concurrent cretostimogene and gemcitabine and sequential cretostimogene and gemcitabine.
48 months

Secondary Outcomes (5)

Cohort A (Arms 1 and 2): Evaluate cretostimogene instillation methods
At 11 and 24 weeks
Cohort A (Arm 3): High-Grade Event-Free Survival at 12 months
At 12 months
Cohort A (Arms 1 and 2) and Cohort B (Arm 1) Duration of response
48 months
Cohort B (Arm 2) High-Grade Event-Free Survival at 12 months
At 12 months
Cohort CX (Arm 1 and 2) Complete response rate
At 11 and 24 weeks

Study Arms (7)

Experimental: Cohort A, Arm 1

EXPERIMENTAL

Cretostimogene (1 x 1012 vp) will be administered intravesically via the current instillation method