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Imprime PGG

Phase 2

Malignant Neoplasm of Breast | Monoclonal antibody | Oncology |Merck & Company, Inc.|Last Updated: Jun 22, 2023

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment26

FDA Designations

No designations recorded

Clinical trial landscape

Imprime PGG · 1 trial · 1 indication

Phase 2 1
NCT05159778Phase 2 Study of Imprime PGG and Pembrolizumab in Patients With HR+/HER2- Metastatic Breast Cancer (mBCA)Malignant Neoplasm of Breast
COMPLETED26 Analytics
PHASE2COMPLETED
Phase 2 Study of Imprime PGG and Pembrolizumab in Patients With HR+/HER2- Metastatic Breast Cancer (mBCA)
Malignant Neoplasm of BreastUnlock trial analytics

Study Endpoints

Primary Endpoints

Overall response rate (ORR)
Within 24 months of last patient enrolled

ORR by RECIST v1.1 following treatment with Imprime PGG + pembrolizumab

Secondary Endpoints

Median Progression Free Survival (mPFS)
Within 24 months of last patient enrolled
PFS at 6, 9, 12, 18, and 24 months
Within 24 months of last patient enrolled
Median Overall Survival (mOS)
Within 48 months of last patient enrolled
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
ExperimentalEXPERIMENTAL -

Interventions

NameTypeDescription
Imprime PGGBIOLOGICALImprime 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.
PembrolizumabBIOLOGICALPembrolizumab 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.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites16

Inclusion Criteria: 1. The patient (or legally acceptable representative if applicable) provides written informed consent for the trial. 2. Be 18 years of age on day of signing informed consent. 3. Have historically confirmed histological diagnosis of metastatic ER/PR+/HER2(-) subtype breast cancer...

Countries:United States
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Frequently asked questions about Imprime PGG

What is Imprime PGG used for in malignant neoplasm of breast?

Imprime PGG is an investigational monoclonal antibody being studied for the treatment of malignant neoplasm of breast, specifically in patients with HR+/HER2- metastatic breast cancer. It is being evaluated in combination with pembrolizumab in a Phase 2 clinical trial.

Who makes Imprime PGG?

Imprime PGG is being developed by Merck & Company, Inc., which trades under the ticker symbol MRK. The company is conducting clinical research on this investigational therapy for oncology indications.

What phase is Imprime PGG in?

Imprime PGG is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to evaluate its safety and efficacy in patients.

What clinical trials is Imprime PGG in?

Imprime PGG is being studied in a Phase 2 clinical trial with the identifier NCT05159778. This trial, titled 'Phase 2 Study of Imprime PGG and Pembrolizumab in Patients With HR+/HER2- Metastatic Breast Cancer (mBCA)', has been completed and enrolled 26 participants in the United States.

Is Imprime PGG a monoclonal antibody?

Yes, Imprime PGG is a monoclonal antibody. It is being investigated as a therapeutic agent in oncology, specifically for the treatment of malignant neoplasm of breast, and is currently in Phase 2 clinical development.