Clinical trialNCT05159778CompletedPhase 2Interventional

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

SponsorHiberCell, Inc.Enrollment26Malignant Neoplasm of Breast

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

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Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Alison Stopeck, MD
Stony Brook University
Study Chair
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A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

16 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

the University of Arizona Cancer Center
Tucson, Arizona, United States
the University of Arizona Cancer Center - North Campus
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
Stony Brook University
Stony Brook, New York, United States
Thomas Jefferson University- Sidney Kimmel Cancer Center
Philadelphia, Pennsylvania, United States
Baptist Clinical Research Institute
Memphis, Tennessee, United States
the University of Texas Md Anderson Cancer Center
Houston, Texas, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

OdetiglucanPembrolizumab →

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 9 Nov 2021
Primary completion: 22 Mar 2023
Completion: 12 Apr 2023
Last update posted: 22 Jun 2023
Registered enrollment: 26
Registry id: NCT05159778

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.