IRX-2

also known as Cytokine-based biologic agent irx-2

Developed for: oral cavity squamous cell carcinoma · head and neck squamous cell carcinoma · oropharynx squamous cell carcinoma · breast cancer · gastric adenocarcinoma · gastroesophageal junction adenocarcinoma · hepatocellular carcinoma · hypopharynx squamous cell carcinoma
+8 more
· laryngeal squamous cell carcinoma · metastatic malignant neoplasm · non-small cell lung carcinoma · paranasal sinus squamous cell carcinoma · renal cell carcinoma · urothelial carcinoma · uterine cervix carcinoma in situ · vulvar intraepithelial neoplasia
Investigated by: Brooklyn ImmunoTherapeutics, LLC · National Cancer Institute (NCI) · City of Hope Medical Center · H. Lee Moffitt Cancer Center and Research Institute · AstraZeneca · Bristol-Myers Squibb
+4 more
· Emory University · Merck Sharp & Dohme LLC · Providence Health & Services · University of Southern California

Trials 9

today NCT04373031 · Ph 2 NCT03575234 · Ph 1 NCT03381183 · Ph 1 NCT03918499 · Ph 1/2 NCT03655002 · Ph 1 NCT03758781 · Ph 1 NCT03267680 · Ph 2 NCT02609386 · Ph 2 NCT00210470 · Ph 2

20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Phase 14 trials · 1 met primary
Phase 1	NCT03575234	Jul 2020 → Jan 2026	oral cavity squamous cell carcinoma, oropharynx squamous cell carcinoma	Emory University	Withdrawn	No outcome recorded Stop: Business
Phase 1	NCT03381183	Aug 2019 → May 2022	hypopharynx squamous cell carcinoma, laryngeal squamous cell carcinoma, oral cavity squamous cell carcinoma, oropharynx squamous cell carcinoma +1	H. Lee Moffitt Cancer Center and Research Institute	Completed	Met primary
Phase 1	NCT03655002	Feb 2019 → Mar 2027 expected	hepatocellular carcinoma	City of Hope Medical Center	Active not recruiting	No outcome recorded
Phase 1	NCT03758781	Feb 2019 → Feb 2021	head and neck squamous cell carcinoma, metastatic malignant neoplasm, non-small cell lung carcinoma, renal cell carcinoma +1	H. Lee Moffitt Cancer Center and Research Institute	Completed	No outcome recorded
Phase 1/21 trial
Phase 1/2	NCT03918499	Apr 2019 → Feb 2023	gastric adenocarcinoma, gastroesophageal junction adenocarcinoma	City of Hope Medical Center	Completed	No outcome recorded
Phase 24 trials · 1 missed
Phase 2	NCT04373031	Dec 2020 → Jul 2023 overdue	breast cancer	Providence Health & Services	Active not recruiting	No outcome recorded
Phase 2	NCT03267680	Nov 2017 → Aug 2023	uterine cervix carcinoma in situ, vulvar intraepithelial neoplasia	University of Southern California	Terminated	No outcome recorded
Phase 2	NCT02609386	Jan 2016 → Feb 2022	oral cavity squamous cell carcinoma	Brooklyn ImmunoTherapeutics, LLC	Completed	Missed primary
Phase 2	NCT00210470	Jul 2005 → Dec 2010	head and neck squamous cell carcinoma	Brooklyn ImmunoTherapeutics, LLC	Completed	No outcome recorded

Evidence & citations 5 cited values

Every value below carries the sentence it was read from. 10 sources stand behind the page.

Field	Value	Cited text
Known as	IRX 2	“IRX-2, is a cell-derived biologic with multiple active cytokine components that acts on multiple cell types of the immune system including T cells, dendritic cells and natural...” NCT04373031 ↗ 10 “subcutaneous IRX-2 injections for 10 days between Days 4 and 18” NCT03758781 ↗ “Drug: IRX 2” NCT03758781 ↗ “Drug: IRX 2” NCT04373031 ↗ NCT03918499 ↗ NCT03267680 ↗ NCT03381183 ↗ NCT02609386 ↗ NCT03655002 ↗ NCT00210470 ↗ NCT03575234 ↗
Known as	Cytokine-based biologic agent irx-2	ChEMBL registry synonym — accepted as the source's own label CHEMBL4594479 ↗
Action	Restore	“restores immune function and activates a coordinated immune response against the tumor” NCT00210470 ↗
Modality	Protein / enzyme biologic	“IRX-2 is a primary cell-derived biologic” NCT00210470 ↗
Route	Subcutaneous	“IRX-2 for 10 days (2 s.c. injections of 1 mL each day) into bilateral mastoid insertion regions.” NCT00210470 ↗