Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CG0070 · 2 trials · 2 indications
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 |
|---|---|---|
| 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 |
|---|---|---|
| CG0070 | BIOLOGICAL | Engineered Oncolytic Adenovirus |
| Pembrolizumab Injection | BIOLOGICAL | Immune checkpoint inhibitor, Monoclonal antibody |
| n-dodecyl-B-D-maltoside | OTHER | Transduction-enhancing agent. |
Key Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2 * Pathologically confirmed NMIBC with CIS (with or without Ta/T1 disease) * Unresponsive to prior BCG therapy (Lerner 2015) defined as persistent or recurrent CIS alone or with recurrent Ta/T1 (noninvasive...