Product Description
AMG319 is a PI3Kdelta inhibitor. Preclinically, target inhibition abrogates Treg mediated immunosuppression, augmenting CD8+ T-cell anti-tumour activity. (Sourced from: https://ascopubs.org/doi/10.1200/JCO.2018.36.15_suppl.6068)
Mechanisms of Action: PI3K Inhibitor
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: None *
Approval Status: Not Approved
Approved Countries: None
Approved Indications: None
Known Adverse Events: None
Company: Amgen
Company Location: THOUSAND OAKS CA 91320
Company CEO:
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic:
Active Clinical Trial Count:
Highest Development Phases
Phase 2: Squamous Cell Carcinoma|Head and Neck Cancer|Papilloma
Phase 1: Chronic Lymphoid Leukemia|T-Cell Lymphoma|Diffuse Large B-Cell Lymphoma|T-Cell Leukemia|Lymphocytic Chronic B-Cell Leukemia|Mantle-Cell Lymphoma|Lymphoma, Non-Hodgkin
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| 2014-004388-20 | P2 |
Terminated |
Squamous Cell Carcinoma|Papilloma|Head and Neck Cancer |
2018-05-03 |
|
| CRUKD/15/004 | P2 |
Terminated |
Squamous Cell Carcinoma|Head and Neck Cancer|Papilloma |
2018-05-03 |
|
| AMG 319 FIH Lymphoid | P1 |
Completed |
Lymphoma, Non-Hodgkin|Lymphocytic Chronic B-Cell Leukemia|T-Cell Leukemia|Mantle-Cell Lymphoma|T-Cell Lymphoma|Chronic Lymphoid Leukemia|Diffuse Large B-Cell Lymphoma |
2013-10-01 |