Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AMG 319 · 1 trial · 14 indications
| Arm | Type | Description |
|---|---|---|
| Part II Dose Expansion | EXPERIMENTAL | Dose selected from Part I dose exploration |
| Part I Dose Exploration | EXPERIMENTAL | The AMG 319 doses proposed for this study are 25, 50, 100, 200, 300 and 400 mg administered by mouth once daily. |
| Name | Type | Description |
|---|---|---|
| AMG 319 | DRUG | AMG 319 is a highly selective, orally bioavailable and potent small molecule inhibitor of PI3Kδ. |
Inclusion Criteria: \- Part 1 (Dose Exploration): Relapsed or refractory lymphoid malignancy of the following type for which standard treatment does not exist or is no longer effective: B-cell Chronic Lymphocytic Leukemia (CLL) confirmed by immunophenotype or Non-Hodgkin Lymphoma: Low or intermedi...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| GE Healthcare Technologies Inc. | GEHC | 1 | PHASE1 | GEH200520/ GEH200521- Part A |
| Zimmer Biomet Holdings, Inc. | ZBH | 1 | - | Undisclosed |
| Ascentage Pharma Group International Unsponsored ADR | AAPG | 1 | PHASE1 | Olverembatinib |
AMG 319 is an investigational small molecule being developed for the treatment of cancer, including hematologic malignancies such as chronic lymphocytic leukemia, diffuse large cell lymphoma, low grade lymphoma, mantle cell lymphoma, non-Hodgkin's lymphoma, and T cell lymphoma. It is currently in Phase 1 clinical development.
AMG 319 is being developed by Amgen Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol AMGN. The drug is an investigational small molecule in Phase 1 clinical development for oncology indications.
AMG 319 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 clinical trial has been completed, and the drug remains under investigation for the treatment of cancer.
AMG 319 has been studied in a Phase 1 first-in-human clinical trial identified as NCT01300026, titled "AMG 319 Lymphoid Malignancy FIH." This completed trial enrolled 28 participants in the United States and evaluated the drug in patients with various hematologic malignancies and solid tumors.
AMG 319 is a distinct investigational small molecule developed by Amgen Inc. It is not known to be the same as any other approved or marketed drug. It is being studied specifically for its potential use in treating cancer and hematologic malignancies.