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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: Completed Phase 2 study of Malignant Neoplasm of Breast, sponsored by HiberCell.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
ORR by RECIST v1.1 following treatment with Imprime PGG + pembrolizumab
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2021-11-09 |
| Est. Completion | 2023-04-12 |
| Phase | Phase 2 |
What the finished NCT05159778 record still lists
NCT05159778 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 59-participant average among 10 other Malignant Neoplasm of Breast trials with a reported enrollment target (56% lower).
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 lists 16 locations in 12 states (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.
Learn More About Clinical Trials
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Where NCT05159778's enrollment target sits among peer trials
26 8th of 10 higher than 3 of 10 other Malignant Neoplasm of Breast trials
participants (enrollment target), bucketed by value
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