Clinical trial · Interventional
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)
NCT06567743CI-TRIAL-00125786recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| High-Risk Non-Muscle-Invasive Bladder Cancer | Bladder Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cretostimogene Grenadenorepvec | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (7)
- type
- EXPERIMENTAL
- label
- Experimental: Cohort A, Arm 1
- description
- Cretostimogene (1 x 1012 vp) will be administered intravesically via the current instillation method
- interventionNames
- Drug: Cretostimogene Grenadenorepvec
- type
- EXPERIMENTAL
- label
- Experimental: Cohort A, Arm 2
- description
- Cretostimogene (1 x 1012 vp) will be administered intravesically via an alternative instillation method.
- interventionNames
- Drug: Cretostimogene Grenadenorepvec
- type
- EXPERIMENTAL
- label
- Experimental: Cohort A, Arm 3
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Cohort A Key Inclusion Criteria: * 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. Cohort B Key Inclusion Criteria: * 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. * 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. Cohort CX Inclusion Criteria * Pathologically confirmed high-risk high-grade BCG-unresponsive or BCG-exposed 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. Key Exclusion Criteria (Both Cohorts): * 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. * Cohort CX Only: serial intravesical gemcitabine within 24 months
References
Publications (0)
Data not yet available
No reference posted for this study.