Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as PRGN-2012 - Phase I; Dose Level 1, PRGN-2012- Phase I; Dose Level 1, PRGN-2012 - Phase II; Dose Level 2, PRGN-2012- Phase II; Dose Level 2
PRGN-2012 · 1 trial · 3 indications
A complete response is defined as no requirement for surgical intervention in the 12 months after treatment
The incidence of dose limiting toxicities in Phase 1 will be reported per dose level. The dose level at which less than or equal to 1 out of 6 patients experience DLT will be identified as a RP2D.
| Arm | Type | Description |
|---|---|---|
| Phase I; Dose Level 1 | EXPERIMENTAL | A standard dose escalation design was used to evaluate PRGN-2012 at a dose level of 1 × 10\^11 |
| Phase I; Dose Level 2 | EXPERIMENTAL | A standard dose escalation design was used to evaluate PRGN-2012 at a dose level of 5 × 10\^11 |
| Phase II; Dose Level 2 | EXPERIMENTAL | A dose of 5 x 10\^11 PU was established as the RP2D, and the Phase 2 portion was implemented. The Phase 2 portion is designed as a dose expansion study, where patients were treated at the RP2D to evaluate the safety and efficacy of PRGN-2012. |
| Name | Type | Description |
|---|---|---|
| PRGN-2012 - Phase I; Dose Level 1 | DRUG | In Phase 1, dose level 1 of the clinical trial, PRGN-2012 is administered at 1 × 10\^11 particle units as adjuvant therapy prior to standard debulking surgery. |
| PRGN-2012 - Phase I; Dose Level 2 | DRUG | In Phase 1, dose level 2 of the clinical trial, PRGN-2012 is administered at 5 × 10\^11 particle units as adjuvant therapy prior to standard debulking surgery. |
| PRGN-2012 - Phase II; Dose Level 2 | DRUG | The Phase 2 portion is designed as a dose expansion study where patients are treated at the RP2D of 5 x 10\^11 PU. |
INCLUSION CRITERIA: * Age 18 years and older * Clinical diagnosis of RRP * Histological diagnosis of papilloma confirmed by pathology report from a CLIA-certified (or comparable) laboratory * Presence of laryngotracheal papillomas with or without pulmonary RRP * A history of 3 or more interv...