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

ConditionHigh-Risk Non-Muscle-Invasive Bladder Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCG Oncology, Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Pathologically confirmed BCG-naïve high-risk high-grade NMIBC (i.e., CIS with or without Ta/T1 disease or high-grade Ta/T1 papillary-only disease without CIS) within 90 days of treatment allocation.

All visible disease must be resected, and all CIS resected or fulgurated, as feasible within 90 days prior to treatment allocation.

Acceptable baseline organ function.

Pathologically confirmed BCG-exposed high-risk high-grade NMIBC (i.e., CIS with or without Ta/T1 disease or high-grade Ta/T1 papillary-only disease without CIS) within 90 days of treatment allocation.

Disqualifiers

Current or past history of muscle-invasive, locally advanced or metastatic bladder cancer.

High-grade urothelial carcinoma in the upper urinary tract or prostatic urethra within 24 months or T2 in upper tract within 48 months or any history of locally advanced/ nodal or metastatic disease in the upper urinary tract.

Significant immunodeficiency.

Pregnant or breastfeeding.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Cretostimogene Grenadenorepvec

    Drug

    Respective Cohort

Treatment groups

325 Participants
are divided into 7 treatment groups

7

Treatment groups

See each treatment group below.

Group A: Experimental: Cohort A, Arm 1Experimental treatment 1 intervention
Group B: Experimental: Cohort A, Arm 2Experimental treatment 1 intervention
Group C: Experimental: Cohort A, Arm 3Experimental treatment 1 intervention
Group D: Experimental: Cohort B, Arm 1Experimental treatment 1 intervention
Group E: Experimental: Cohort B, Arm 2Experimental treatment 1 intervention
Group F: Experimental: Cohort CX, Arm 1Experimental treatment 1 intervention
Group G: Experimental: Cohort CX, Arm 2Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
At 11 and 24 weeks
2

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.

Time frame
48 months
3

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.

Time frame
At 11 and 24 weeks
4

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.

Time frame
48 months

Secondary outcomes

1

Cohort A (Arms 1 and 2): Evaluate cretostimogene instillation methods

Evaluate 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.

Time frame
At 11 and 24 weeks
2

Cohort A (Arm 3): High-Grade Event-Free Survival at 12 months

Determine the proportion of participants with BCG-naive papillary-only high-grade NMIBC at baseline who are free from high-grade events at 12 months

Time frame
At 12 months
3

Cohort A (Arms 1 and 2) and Cohort B (Arm 1) Duration of response

Assess duration of response in participants with CIS with or without concomitant HG Ta/T1 disease at baseline

Time frame
48 months
4

Cohort B (Arm 2) High-Grade Event-Free Survival at 12 months

Determine the proportion of participants with BCG-exposed papillary-only high-grade NMIBC at baseline who are free from high-grade events at 12 months

Time frame
At 12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

CG Oncology, Inc.

Lead sponsor

Source ClinicalTrials.gov
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