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NCT05159778 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Malignant Neoplasm of Breast, sponsored by HiberCell.

Completed
Registry status
Phase 2
Development phase
26
Enrollment target
16
Study locations

NCT05159778 is a Phase 2 study of Malignant Neoplasm of Breast that has completed, run by HiberCell. The registered enrollment target is 26 participants, below the 59-participant average among 10 other Malignant Neoplasm of Breast trials with a reported enrollment target (56% lower). The trial reports 16 study locations across 12 states.

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The verdict

NCT05159778, a Phase 2 study of Malignant Neoplasm of Breast, has completed, sponsored by HiberCell.

COMPLETED
Registry status
Phase 2
Development phase
26 participants
Enrollment target
16
Study locations

Study Summary

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.

Conditions Studied

Malignant Neoplasm of Breast

Interventions

  • BIOLOGICAL Pembrolizumab
  • BIOLOGICAL Imprime PGG

Study Locations (16)

Florida

  • University of Miami and Clinics -Sylvester Comprehensive Cancer Center - Miami
  • Mt. Sinai (Miami) - Miami Beach
  • Moffitt Cancer Center - Tampa

Arizona

  • The University of Arizona Cancer Center - North Campus - Tucson
  • The University of Arizona Cancer Center - Tucson

New York

  • Columba University Medical Center - New York
  • Stony Brook University - Stony Brook

Colorado

  • University of Colorado at Denver - Denver

Louisiana

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

Minnesota

  • HealthPartners Cancer Research Center - Saint Louis Park

Missouri

  • St. Luke's Cancer Institute - Kansas City

Montana

  • St. Vincent - Frontier Cancer Center - Billings

Trial Details

FieldValue
Enrollment Target 26 participants
Start Date 2021-11-09
Est. Completion 2023-04-12
Phase Phase 2

Sponsor

HiberCell

11 total trials

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What the Registry Record Tells You About NCT05159778

The ClinicalTrials.gov registry entry for NCT05159778 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 26 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 59-participant average among 10 other Malignant Neoplasm of Breast trials with a reported enrollment target (56% lower). The listed sponsor is HiberCell, which has 11 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Malignant Neoplasm of Breast appearing as the primary indexed condition, and to 2 interventions - of which Pembrolizumab is the first listed.

NCT05159778 reports 16 study locations spanning 12 distinct geographic areas - top geographies include Florida, Arizona, New York.

Frequently Asked Questions

What is clinical trial NCT05159778 about?

NCT05159778 is a clinical study titled "Phase 2 Study of Imprime PGG and Pembrolizumab in Patients With HR+/HER2- Metastatic Breast Cancer (mBCA)". 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 o...

What is the current status of trial NCT05159778?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 26 participants. The study started on 2021-11-09. Estimated completion is 2023-04-12.

What conditions does trial NCT05159778 study?

This clinical trial studies the following conditions: Malignant Neoplasm of Breast.

What interventions are being tested in trial NCT05159778?

The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Imprime PGG (BIOLOGICAL).

Who is sponsoring clinical trial NCT05159778?

This trial is sponsored by HiberCell, which has 11 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05159778 being conducted?

This trial has 16 study locations across Arizona, Colorado, Florida, Louisiana, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.