Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Cretostimogene Grenadenorepvec, oncolytic adenovirus expressing GMCSF, DDM, CG0070 Adenovirus Vector, oncolytic virus, GM-CSF expression, adenoviral vector
CG0070 · 5 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.
Percentage of patients with a complete response as defined by FDA guidance document dated February 2018 for NMIBC.
Defined as the proportion of patients who experience a durable complete response lasting 12 months or longer from the initial confirmed complete response date (first CR assessment to be at least 6 months after the first intravesical intervention) and at least 18 months from the date of the first intravesical intervention
| 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 |
| Single Arm | EXPERIMENTAL | CG0070 will be administered intravesically (IVE) following a sequence of bladder washes with 5% DDM and normal saline. CG0070 will be administered weekly x 6 on Day 1 to Week 6. If the patient shows persistent high-grade disease at Week 13, the patient will receive another cycle of 6 weekly treatments. If there is no disease present at Week 13 (e.g., complete response) then the patient will receive 3 weekly treatments. Beginning at Week 25, patients will receive weekly x 3 treatments every 3 months through Week 49 then every 24 weeks thereafter. Pembrolizumab will be given intravenous (IV) concurrently starting on Day 1 and continue every 6 weeks for up to 2 years. |
| CG0070 | EXPERIMENTAL | Single arm intervention with CG0070 to be given at a dose of 1e12 vp weekly for six weeks. Patients who achieve a partial response or a complete response at 6 months post first intravesical intervention will be maintained with the same induction cycle of weekly times six. Patients will be followed every 3 months through Month 24. |
| Name | Type | Description |
|---|---|---|
| Cretostimogene Grenadenorepvec | DRUG | Engineered Oncolytic Adenovirus |
| n-dodecyl-B-D-maltoside | OTHER | Transduction-enhancing agent |
| CG0070 | BIOLOGICAL | Engineered Oncolytic Adenovirus |
| Pembrolizumab Injection | BIOLOGICAL | Immune checkpoint inhibitor, Monoclonal antibody |
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...
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CG0070 is an investigational gene therapy being developed for bladder cancer, specifically non muscle invasive bladder cancer (NMIBC). It is being studied in patients whose disease has not responded to Bacillus Calmette-Guerin (BCG) therapy. CG0070 has been evaluated in Phase 2 clinical trials in this patient population.
CG0070 is being developed by CG Oncology, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol CGON. The company is focused on developing immunotherapies for bladder cancer, with CG0070 as its lead investigational candidate.
CG0070 is in Phase 2 clinical development. It has completed a Phase 2 trial in non muscle invasive bladder cancer and another Phase 2 trial in combination with pembrolizumab. It is not yet approved by the FDA and remains an investigational therapy.
CG0070 has been studied in two completed Phase 2 trials: NCT04387461, which evaluated CG0070 in combination with pembrolizumab in BCG-unresponsive non muscle invasive bladder cancer, and NCT02365818, which assessed CG0070 as a monotherapy in high-grade NMIBC after BCG failure. Both trials were conducted in the United States, with NCT04387461 also including sites in South Korea.
CG0070 is an oncolytic adenovirus-based gene therapy designed to selectively replicate in and destroy cancer cells. It is engineered to express GM-CSF, which may stimulate an anti-tumor immune response. This mechanism is being investigated for the treatment of non muscle invasive bladder cancer.