Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Cretostimogene Grenadenorepvec · 3 trials · 6 indications
Recurrence free survival (RFS) of cretostimogene after TURBT versus surveillance after TURBT
To determine the Complete Response rate at any time in patients with BCG-unresponsive CIS with or without concomitant HG Ta/T1 papillary disease.
To determine the high-grade EFS of cretostimogene in patients with BCG-unresponsive HG Ta/T1 papillary disease without CIS.Ta/T1 papillary disease without CIS.
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
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.
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.
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.
Determine the High-Grade Event-Free Survival following treatment with cretostimogene in participants with BCG-exposed or BCG-unresponsive high-grade NMIBC.
Determine the safety of concurrent cretostimogene and gemcitabine and sequential cretostimogene and gemcitabine.
| Arm | Type | Description |
|---|---|---|
| Cretostimogene after TURBT | EXPERIMENTAL | Following screening confirmation of IR-NMIBC and complete resection of the tumor, participants will be treated with adjuvant cretostimogene. |
| Observation after TURBT | NO_INTERVENTION | Following screening confirmation of IR-NMIBC and complete resection of tumor, participants will enter surveillance. Participants who recur with IR-NMIBC after TURBT and surveillance will be offered treatment with cretostimogene as per the treatment schedule in Arm A. This arm will be called the Extension Arm. |
| Cohort C(All Countries):Enrollment Closed | EXPERIMENTAL | Patients with CIS with or without HG Ta/T1 papillary disease. Cretostimogene will be administered intravesically following a series of bladder washes with 5% DDM and normal saline. Cretostimogene will be administered weekly x 6 on Weeks 1, 2, 3, 4, 5, and 6. If the patient has disease recurrence at Week 13, they will receive another cycle of 6 weekly treatments. If there is no disease present at Week 13 then the patient will receive 3 weekly treatments. Cohort C(All Countries):Beginning at Week 25, patients will receive weekly x 3 treatments every 12 weeks through week 51 then every 6 months and then a last treatment at Weeks 73, 74, and 75 until the tumor returns or study treatment is completed at Week 97. Cohort C Extension( Japan and the US) At Week 25, patients will receive weekly x 3 treatments every 12 weeks through week 51 then every 6 months starting at Weeks 73, 74, and 75 through Weeks 157, 158, and 159 until the tumor returns or study treatment is completed at Week 159. |
| Cohort P(Japan and United States Only) :Open to Enrollment | EXPERIMENTAL | HG Ta/T1 papillary disease bladder cancer patients. In Cohort P, cretostimogene will be administered at a dose of 1 × 1012vp IVE following instillation of 5% DDM. Cretostimogene will be administered every week for 6 treatments on Weeks 1, 2, 3, 4, 5, and 6. If the patient has recurrence at Week 13 or any timepoint, the patient will receive a second induction of 6 weekly treatments (Weeks 13, 14, 15, 16, 17, and 18.). If the tumor has not returned they will receive 3 weekly treatments every 12 weeks (approximately 3 months) starting Weeks 13, 14, and 15 through Week 51 (approximately 12 months), and then every 6 months starting at Weeks 73, 74, and 75 (approximately 18 months) through Month 36. |
| Experimental: Cohort A, Arm 1 | EXPERIMENTAL | Cretostimogene (1 x 1012 vp) will be administered intravesically via the current instillation method |
| Experimental: Cohort A, Arm 2 | EXPERIMENTAL | Cretostimogene (1 x 1012 vp) will be administered intravesically via an alternative instillation method. |
| Experimental: Cohort A, Arm 3 | EXPERIMENTAL | Cretostimogene (1 x 1012 vp) will be administered intravesically via an alternative instillation method. |
| Experimental: Cohort B, Arm 1 | EXPERIMENTAL | Cretostimogene (1 x 1012 vp) will be administered intravesically via an alternative instillation method. |
| Experimental: Cohort B, Arm 2 | EXPERIMENTAL | Cretostimogene (1 x 1012 vp) will be administered intravesically via an alternative instillation method. |
| Experimental: Cohort CX, Arm 1 | EXPERIMENTAL | At all treatment visits cretostimogene (1 x 1012 vp) will be administered intravesically via an alternative instillation method followed by gemcitabine instilled intravesically |
| Experimental: Cohort CX, Arm 2 | EXPERIMENTAL | Cretostimogene (1 x 1012 vp) will be administered intravesically via an alternative instillation method for two consecutive weeks, followed by gemcitabine administered intravesically in the third week on a cyclic 2:1 visit schedule basis |
| Name | Type | Description |
|---|---|---|
| Cretostimogene Grenadenorepvec | DRUG | Engineered Oncolytic Adenovirus |
| n-dodecyl-B-D-maltoside | OTHER | Transduction-enhancing agent |
Inclusion Criteria: * Pathologically confirmed IR-NMIBC, per American Urologic Association/Society of Urologic Oncology/National Comprehensive Cancer Network guidelines, within 90 days of participant randomization: 1. Recurrent LG Ta within 12 months of prior LG or HG (HG Ta ≤ 3 cm) tumor 2. S...
Cretostimogene grenadenorepvec is an investigational gene therapy being developed for non-muscle-invasive bladder cancer. It is administered intravesically and is designed to target and destroy cancer cells while stimulating an immune response. It is not yet approved and remains in clinical development.
Cretostimogene grenadenorepvec is being studied for the treatment of high-risk non-muscle-invasive bladder cancer, including patients unresponsive to Bacillus-Calmette-Guerin (BCG). It is also being evaluated as adjuvant therapy for intermediate-risk NMIBC following TURBT. It is investigational and not approved for any indication.
Cretostimogene grenadenorepvec is being developed by CG Oncology, Inc., which trades on the Nasdaq under the ticker CGON. The company is focused on advancing this gene therapy for bladder cancer.
Cretostimogene grenadenorepvec is in Phase 2 and Phase 3 clinical development. Two active trials are ongoing, including a Phase 2 study in high-risk NMIBC and a Phase 3 adjuvant study. It has not been approved by the FDA.
Cretostimogene grenadenorepvec is being evaluated in three registered trials: NCT06567743, a Phase 2 study in high-risk NMIBC that is recruiting; NCT06111235, a Phase 3 adjuvant study in intermediate-risk NMIBC that is active but not recruiting; and NCT04452591, a Phase 3 study in BCG-unresponsive NMIBC that is active but not recruiting.
Yes, cretostimogene grenadenorepvec has received both Fast Track and Breakthrough Therapy designations from the FDA. These designations are intended to expedite the development and review of drugs for serious conditions. The therapy is still investigational and has not been approved.