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...
Top 20 of 45 competitors
CG0070 is an investigational oncolytic virus being developed for the treatment of bladder cancer, specifically non-muscle invasive bladder cancer (NMIBC). It is studied in patients with high-grade NMIBC who have failed Bacillus Calmette-Guerin (BCG) therapy. The drug is administered as a regimen to target cancer cells in the bladder.
CG0070 is an oncolytic virus designed to selectively replicate in and destroy cancer cells. It is being evaluated for its ability to induce an anti-tumor immune response. The exact mechanism involves viral infection of tumor cells, leading to cell lysis and potential activation of the immune system against the cancer.
CG0070 is being developed by CG Oncology, Inc., a biopharmaceutical company. The company's stock is traded under the ticker symbol CGON. CG Oncology is focused on developing innovative therapies for the treatment of bladder cancer and other oncological conditions.
CG0070 is currently in Phase 2 clinical development. It has completed two Phase 2 trials, including one studying the drug as a monotherapy and another evaluating it in combination with pembrolizumab. The drug is not yet approved and remains investigational, with ongoing research to assess its safety and efficacy.
CG0070 has been studied in two completed Phase 2 clinical trials. The first trial, NCT02365818, evaluated CG0070 as a single agent in patients with high-grade NMIBC after BCG failure, enrolling 66 participants. The second trial, NCT04387461, studied CG0070 in combination with pembrolizumab in NMIBC unresponsive to BCG, enrolling 35 participants.
CG0070 is a distinct oncolytic virus developed by CG Oncology. It is not the same as other oncolytic viruses like T-VEC or other investigational agents. CG0070 is specifically being studied for bladder cancer, and its mechanism and formulation are unique to CG Oncology's development program.