NCT05159778

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

Completed Phase 2 Last updated 22 June 2023

What this trial tests

Phase 2 trial testing Imprime PGG in Malignant Neoplasm of Breast in 26 participants. Completed in 12 April 2023.

Timeline

9 November 2021

Primary endpoint
22 March 2023

12 April 2023

Quick facts

Lead sponsor	HiberCell, Inc.
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	26
Start date	9 November 2021
Primary completion	22 March 2023
Estimated completion	12 April 2023
Sites	16 locations across United States

Drugs / interventions tested

• Imprime PGG — full drug profile →
• Pembrolizumab (pembrolizumab) — full drug profile →

Conditions studied

• Malignant Neoplasm of Breast — all drugs for Malignant Neoplasm of Breast →

Sponsor

HiberCell, Inc. — full company profile →

Who can join

18 and older, any sex, with Malignant Neoplasm of Breast. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. Altered metabolism in cancer: insights into energy pathways and therapeutic targets.
   Tufail M, Jiang CH, Li N. · · 2024 · cited 265× · PMID 39294640 · DOI 10.1186/s12943-024-02119-3
2. From Cancer Therapy to Winemaking: The Molecular Structure and Applications of β-Glucans and β-1, 3-Glucanases.
   Caseiro C, Dias JNR, de Andrade Fontes CMG, Bule P. · · 2022 · cited 40× · PMID 35328577 · DOI 10.3390/ijms23063156
3. Current and future immunotherapy for breast cancer.
   Heater NK, Warrior S, Lu J. · · 2024 · cited 38× · PMID 39722028 · DOI 10.1186/s13045-024-01649-z
4. Kupffer cells prevent pancreatic ductal adenocarcinoma metastasis to the liver in mice.
   Thomas SK, Wattenberg MM, Choi-Bose S, Uhlik M, et al · · 2023 · cited 34× · PMID 37816712 · DOI 10.1038/s41467-023-41771-z
5. Circulating inflammatory cells in patients with metastatic breast cancer: Implications for treatment.
   Gianni C, Palleschi M, Schepisi G, Casadei C, et al · · 2022 · cited 25× · PMID 36003772 · DOI 10.3389/fonc.2022.882896
6. Imprime PGG Enhances Anti-Tumor Effects of Tumor-Targeting, Anti-Angiogenic, and Immune Checkpoint Inhibitor Antibodies.
   Chan ASH, Kangas TO, Qiu X, Uhlik MT, et al · · 2022 · cited 11× · PMID 35692755 · DOI 10.3389/fonc.2022.869078
7. Myeloid activation clears ascites and reveals IL27-dependent regression of metastatic ovarian cancer.
   Murphy B, Miyamoto T, Manning BS, Mirji G, et al · · 2024 · cited 8× · PMID 39570374 · DOI 10.1084/jem.20231967