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Last Updated: November 20, 2019

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CLINICAL TRIALS PROFILE FOR IRX-5183

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Clinical Trials for IRX-5183

Trial ID Title Status Sponsor Phase Summary
NCT00210470 A Phase 2 Clinical Trial of the Safety and Effects of IRX-2 in Treating Patients With Operable Head and Neck Cancer Completed IRX Therapeutics Phase 2 IRX-2 is designed to activate your own body's immune system so that it can better fight the invasion of head and neck cancer. In pre-clinical studies, IRX-2 has been shown to activate a number of different cells of the immune system. IRX-2 was previously tested in a study of 13 patients with advanced head and neck cancer who had been previously treated and failed chemotherapy and/or radiation therapy. The trials were specifically designed to test the safety of IRX-2. Researchers found that IRX-2 did not appear to have major side effects. Also, the researchers believed that further study in less advanced head and neck cancer patients could be useful in obtaining more data on the safety of IRX-2 as well as data on possible effects on tumors and on patient survival.
NCT02609386 IRX-2 Regimen in Patients With Newly Diagnosed Stage III or IVA Squamous Cell Carcinoma of the Oral Cavity Recruiting IRX Therapeutics Phase 2 The purpose of this study is to determine whether a pre-operative regimen of the study drug, IRX-2, a human cell-derived biologic with multiple active cytokine components, plus a single dose of cyclophosphamide, followed by 21 days of indomethacin, zinc-containing multivitamins, and omeprazole is active in treatment of oral cavity cancer. The regimen is intended to stimulate an immune response against the cancer.
NCT02950259 Pre-operative IRX-2 in Early Stage Breast Cancer (ESBC) Not yet recruiting IRX Therapeutics Phase 1 The goal of this study is assess the safety and tolerability of the IRX-2 regimen in patients with early stage breast cancer (ESBC).
NCT02950259 Pre-operative IRX-2 in Early Stage Breast Cancer (ESBC) Not yet recruiting Providence Health & Services Phase 1 The goal of this study is assess the safety and tolerability of the IRX-2 regimen in patients with early stage breast cancer (ESBC).
NCT03267680 Cyclophosphamide and IRX-2 in Treating Women With Cervical Squamous Intraepithelial Neoplasia 3 or Squamous Vulvar Intraepithelial Neoplasia 3 Not yet recruiting National Cancer Institute (NCI) Phase 2 This randomized phase II trial studies how well cyclophosphamide and IRX-2 work in treating women with cervical squamous intraepithelial neoplasia 3 or squamous vulvar intraepithelial neoplasia 3. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. IRX-2 may act as an immune booster to stimulate the immune system. Giving cyclophosphamide and IRX-2 may work better at treating cervical squamous intraepithelial neoplasia or squamous vulvar intraepithelial neoplasia.
>Trial ID >Title >Status >Phase >Summary

Clinical Trial Conditions for IRX-5183

Condition Name

Condition Name for
Intervention Trials
Squamous Cell Carcinoma of the Head and Neck 2
Breast Neoplasm, Male 1
Stage IV Hepatocellular Carcinoma AJCC v8 1
NSCLC 1
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Condition MeSH

Condition MeSH for
Intervention Trials
Carcinoma, Squamous Cell 5
Carcinoma 4
Head and Neck Neoplasms 3
Neoplasms 2
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Clinical Trial Locations for IRX-5183

Trials by Country

Trials by Country for
Location Trials
United States 28
Kuwait 1
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Trials by US State

Trials by US State for
Location Trials
California 5
Georgia 2
Pennsylvania 2
New York 2
Michigan 2
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Clinical Trial Progress for IRX-5183

Clinical Trial Phase

Clinical Trial Phase for
Clinical Trial Phase Trials
Phase 2 4
Phase 1/Phase 2 2
Phase 1 3
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Clinical Trial Status

Clinical Trial Status for
Clinical Trial Phase Trials
Not yet recruiting 7
Completed 1
Recruiting 1
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Clinical Trial Sponsors for IRX-5183

Sponsor Name

Sponsor Name for
Sponsor Trials
IRX Therapeutics 4
National Cancer Institute (NCI) 3
City of Hope Medical Center 2
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Sponsor Type

Sponsor Type for
Sponsor Trials
Other 7
Industry 5
NIH 3
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