Immuno-Oncology

Our Immuno-Oncology Clinical Studies

Locally Advanced Pancreatic Adenocarcinoma Pancreatic

Phase of Development
Phase 2
Status
Study Launch Expected in Q1 2023
Number of Subjects
Up to 90
Study Drug
Ampligen® Following FOLFIRINOX
Primary Endpoint
PFS
Secondary Endpoint
OS, ORR, DoR
Clinical Trials NCT #
NCT05494697

Late-Stage Pancreatic Cancer

Phase of Development
Early Access Program
Status
Ongoing
Number of Subjects
40+
Study Drug
Ampligen® Monotherapy
Primary Endpoint
Safety and Efficacy
Study Partner
Erasmus MC
Data Publication
Positive Results
Published March 2022

Advanced, Recurrent Ovarian Cancer

Phase of Development
Phase 1/2
Status
Interim Data Published April 2022
Number of Subjects
45
Study Drug
Ampligen®; Cisplatin; Pembrolizumab
Primary Endpoint
Objective Response Rate (ORR)
Study Partner
University of Pittsburgh
Clinical Trials NCT #
NCT03734692

Recurrent Ovarian Cancer

Phase of Development
Phase 1/2
Status
Number of Subjects
25
Study Drug
Ampligen®; Cisplatin; Celecoxib; DC vaccine
Primary Endpoint
Treatment
Study Partner
University of Pittsburgh
Clinical Trials NCT #
NCT02432378

Metastatic Triple Negative Breast Cancer

Phase of Development
Phase 1
Status
Data Published April 2022
Number of Subjects
8
Study Drug
Ampligen®; Celecoxib; Pembrolizumab; Recombinant Interferon Alfa-2b
Primary Endpoint
Overall response rate (ORR)
Study Partner
Roswell Park Cancer Institute
Clinical Trials NCT #
NCT03599453

Early-Stage Triple Negative Breast Cancer

Phase of Development
Phase 1
Status
Analyzing Data
Number of Subjects
24
Study Drug
Ampligen®; Celecoxib; Cyclophosphamide; Doxorubicin Hydrochloride; Paclitaxel; Recombinant Interferon Alfa-2b
Primary Endpoint
Tumor-infiltrating CD8+ cytotoxic T lymphocyte (CTL)s
Study Partner
Roswell Park Cancer Institute
Clinical Trials NCT #
NCT04081389

Colorectal Cancer Metastatic to the Liver

Phase of Development
Phase 2a
Status
Final Data Published April 2022
Number of Subjects
19
Study Drug
Ampligen®; Celecoxib; Recombinant Interferon Alfa-2b
Primary Endpoint
Change in Tumor-infiltrating Lymphocytes (TILs) in the Colorectal Cancer Lesions
Study Partner
Roswell Park Cancer Institute
Clinical Trials NCT #
NCT03403634

COVID-19 in Cancer Patients

Phase of Development
Phase 1/2
Status
Recruiting
Number of Subjects
Up to 64
Study Drug
Ampligen® and IFN alpha-2b
Primary Endpoint
Incidence of AEs, Kinetics of Viral Load
Study Partner
Roswell Park
Clinical Trials NCT #
NCT04379518

Refractory Melanoma

Phase of Development
Phase 2
Status
Enrollment Ongoing
Number of Subjects
24
Study Drug
Ampligen®; Celecoxib; PD-1 Ligand Inhibitor; PD1 Inhibitor; Recombinant Interferon Alfa-2b
Primary Endpoint
Objective response rate (ORR)
Study Partner
Roswell Park Cancer Institute
Clinical Trials NCT #
NCT04093323