Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05159778 | Phase 2 Study of Imprime PGG and Pembrolizumab in Patients With HR+/HER2- Metastatic Breast Cancer (mBCA) | PHASE2 | COMPLETED | 26 | — | — | Nov 9, 2021 | Apr 12, 2023 | Jun 22, 2023 | 16 | United States |
ORR by RECIST v1.1 following treatment with Imprime PGG + pembrolizumab
| Arm | Type | Description |
|---|---|---|
| Experimental | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Imprime PGG | BIOLOGICAL | Imprime PGG is a soluble, β-1,3/1,6 glucan isolated from the cell wall of a proprietary Saccharomyces cerevisiae yeast strain. Imprime PGG acts as a Pathogen-Associated Molecular Pattern (PAMP). Imprime will be administered at a dose of 4 mg/kg IV over a 2-hour infusion time on Days 1, 8 and 15 of each 3-week treatment cycle. |
| Pembrolizumab | BIOLOGICAL | Pembrolizumab is a humanized monoclonal antibody against the programmed death receptor-1 protein. Pembrolizumab will be given at a fixed dose of 200 mg IV over 30 minutes on Day 1 of each 3-week treatment cycle after the Imprime infusion. |
Inclusion Criteria: 1. The patient (or legally acceptable representative if applicable) provides written informed consent for the trial. 2. Be 18 years of age on day of signing informed consent. 3. Have historically confirmed histological diagnosis of metastatic ER/PR+/HER2(-) subtype breast cancer...