Phase 2 Study of Imprime PGG and Pembrolizumab in Patients With HR+/HER2- Metastatic Breast Cancer (mBCA)

PHASE2CompletedINTERVENTIONAL
Enrollment

26

Participants

Timeline

Start Date

November 9, 2021

Primary Completion Date

March 22, 2023

Study Completion Date

April 12, 2023

Conditions
Malignant Neoplasm of Breast
Interventions
BIOLOGICAL

Imprime PGG

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.

BIOLOGICAL

Pembrolizumab

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.

Trial Locations (16)

10032

The University of Arizona Cancer Center - North Campus, Tucson

Columba University Medical Center, New York

11794

Stony Brook University, Stony Brook

19107

Thomas Jefferson University- Sidney Kimmel Cancer Center, Philadelphia

33136

University of Miami and Clinics -Sylvester Comprehensive Cancer Center, Miami

33140

Mt. Sinai (Miami), Miami Beach

33612

Moffitt Cancer Center, Tampa

38120

Baptist Clinical Research Institute, Memphis

55426

HealthPartners Cancer Research Center, Saint Louis Park

59102

St. Vincent - Frontier Cancer Center, Billings

64111

St. Luke's Cancer Institute, Kansas City

70112

Louisiana State University Health Sciences Center - New Orleans, New Orleans

77030

The University of Texas MD Anderson Cancer Center, Houston

80045

University of Colorado at Denver, Denver

85719

The University of Arizona Cancer Center, Tucson

87131

University of New Mexico Comprehensive Cancer Center, Albuquerque

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Merck Sharp & Dohme LLC

INDUSTRY

lead

HiberCell, Inc.

INDUSTRY

NCT05159778 - Phase 2 Study of Imprime PGG and Pembrolizumab in Patients With HR+/HER2- Metastatic Breast Cancer (mBCA) | Biotech Hunter | Biotech Hunter