Condition: Malignant Neoplasm of Breast · Sponsor: HiberCell, Inc.
The primary objective of this Phase 2 Simon 2-Stage study is to determinate the Overall Response Rate (ORR) per RECIST v1.1 following treatment with Imprime PGG + pembrolizumab in patients with ER/PR+/ HER2(-) metastatic breast cancer who have progressed through prior hormone therapy with at least one CDK4/6 inhibitor, and a maximum of 2 subsequent chemotherapy treatment. Patients will be screened for baseline anti-β glucan antibody level (ABA; measured in peripheral blood). Those patients with an ABA greater than or equal to 20 mcg/ml and meeting all other I/E criteria, will be enrolled. The study will enroll 47 patients with 23 patients enrolled into Stage 1. If 4 or more patients in Stage 1 have an objective response after 12 weeks of treatment, the study will proceed into Stage 2. A total of 24 patients will be enrolled in Stage 2 for a total combined population of 47. Overall, objective responses must be observed in 10 patients for the study to be declared a success.
This description comes directly from the study's public registry record.
Contact details are listed per location below or on the registry record.
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| The University of Arizona Cancer Center - North Campus | Tucson, Arizona, United States | — |
| The University of Arizona Cancer Center | Tucson, Arizona, United States | — |
| University of Colorado at Denver | Denver, Colorado, United States | — |
| University of Miami and Clinics -Sylvester Comprehensive Cancer Center | Miami, Florida, United States | — |
| Mt. Sinai (Miami) | Miami Beach, Florida, United States | — |
| Moffitt Cancer Center | Tampa, Florida, United States | — |
| Louisiana State University Health Sciences Center - New Orleans | New Orleans, Louisiana, United States | — |
| HealthPartners Cancer Research Center | Saint Louis Park, Minnesota, United States | — |
| St. Luke's Cancer Institute | Kansas City, Missouri, United States | — |
| St. Vincent - Frontier Cancer Center | Billings, Montana, United States | — |
| University of New Mexico Comprehensive Cancer Center | Albuquerque, New Mexico, United States | — |
| Columba University Medical Center | New York, New York, United States | — |
+ 4 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT05159778