Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CPI-006 · 2 trials · 14 indications
Incidence of adverse events (including serious adverse events and dose limiting toxicities).
Measure changes in serum or plasma immunoglobulin anti-SARS CoV-2 levels.
| Arm | Type | Description |
|---|---|---|
| CPI-006 Dose Escalation | EXPERIMENTAL | CPI-006 + Standard of Care |
| Control Arm | OTHER | Standard of Care Only |
| Cohort 1a | EXPERIMENTAL | CPI-006 |
| Cohort1b | EXPERIMENTAL | CPI-006 + ciforadenant |
| Cohort 1c | EXPERIMENTAL | CPI-006 + pembrolizumab |
| Cohort 2a | EXPERIMENTAL | CPI-006 |
| Cohort 2b | EXPERIMENTAL | CPI-006 + ciforadenant |
| Cohort 2c | EXPERIMENTAL | CPI-006 + pembrolizumab |
| Name | Type | Description |
|---|---|---|
| CPI-006 | DRUG | Participants will receive a single dose of CPI-006 at one of four dose levels (0.3 mg/kg, 1.0 mg/kg, 3.0 mg/kg, or 5.0 mg/kg) along with standard of care. |
| Standard of Care | OTHER | Participants will receive standard of care treatment only. |
| CPI-006 + ciforadenant | DRUG | Subjects will receive escalating doses of CPI-006 administered intravenously once every 21 days in combination with CPI-444 orally twice daily until MTD is reached for CPI-006 or until disease progression. |
| CPI-006 + pembrolizumab | DRUG | Subjects will receive escalating doses of CPI-006 in combination with pembrolizumab administered intravenously once every 21 days until MTD is reached for CPI-006 or until disease progression. |
Inclusion Criteria: * Nasal swab test positive by reverse transcriptase PCR for SARS CoV-2 within past 7 days, and onset of COVID-19 symptoms no more than 10 days prior to the positive test * Hospitalized and have stable mild to moderate symptoms of COVID-19 * Blood oxygen saturation of a minimum o...