Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AMG 404 · 1 trial · 1 indication
Toxicities were graded with the Common Terminology Criteria for Adverse Events CTCAE v5.0., the following toxicities were classified as DLTs: * Any treatment related grade 5 toxicity * Grade 4 neutropenia or thrombocytopenia * Febrile neutropenia * Grade 4 anemia * Grade 3 or 4 non-hematologic toxicity * Recurrent grade 2 pneumonitis * Any other toxicity requiring permanent discontinuation of AMG 404.
A TEAE is any adverse event (AE) starting on or after the first administration of investigational product (IP) and up to and including 140 days after the last IP dose date or end of the study, whichever occurs earlier. A TEAE with unknown/missing relatedness to AMG 404 is assumed as an event is related to AMG 404. A serious adverse event (SAE) is defined as an adverse event that: is fatal, is life threatening, requires in-patient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, and other medically important serious event. A treatment-related AE (TRAE) is any TEAE that per investigator review has a reasonable possibility of being caused by the investigational product. In the unlikely event that the relationship is missing, the TEAE will be considered TRAE and documented in a footnote of the treatment-related summary.
| Arm | Type | Description |
|---|---|---|
| Cohort 1 | EXPERIMENTAL | Cohort 1 |
| Cohort 2 | EXPERIMENTAL | Cohort 2 |
| Cohort 3 | EXPERIMENTAL | Cohort 3 |
| Cohort 4 | EXPERIMENTAL | Cohort 4 |
| Cohort 6 | EXPERIMENTAL | Cohort 6 |
| Cohort 7 | EXPERIMENTAL | Cohort 7 |
| Cohort 8 | EXPERIMENTAL | Cohort 8 |
| Cohort 9 | EXPERIMENTAL | Cohort 9 |
| Name | Type | Description |
|---|---|---|
| AMG 404 | DRUG | AMG 404 will be examined for safety, tolerability, PK, and PD of AMG 404 in subjects with advanced solid tumors. |
Inclusion Criteria: * Subject has provided informed consent prior to initiation of any study specific activities/procedures. * Age greater than or equal to 18 years old at the time of signing informed consent. * Life expectancy of greater than 3 months, in the opinion of the investigator * Subject ...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 2 | PHASE2 | pembrolizumab |
| Incyte Corporation | INCY | 1 | PHASE2 | Chemotherapy, Retifanlimab |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | E7 TCR-T cells, Aldesleukin |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115, pembrolizumab |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
AMG 404 is an investigational small molecule being developed for the treatment of advanced solid tumors. It is designed to target PD-1, a protein involved in immune regulation. The drug is currently in Phase 1 clinical development, with one completed trial evaluating its safety and efficacy in patients with advanced solid tumors.
AMG 404 targets PD-1, a protein that plays a role in immune checkpoint regulation. By targeting PD-1, the drug aims to modulate the immune response against cancer cells. This mechanism is being studied in the context of advanced solid tumors, where PD-1 inhibition may help restore anti-tumor immunity.
AMG 404 is developed by Amgen Inc., a biopharmaceutical company listed on NASDAQ under the ticker AMGN. The drug is being investigated as a potential treatment for advanced solid tumors and is currently in Phase 1 clinical development.
AMG 404 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The drug is being studied for the treatment of advanced solid tumors, with one Phase 1 trial completed that enrolled 171 participants.
AMG 404 has been studied in a Phase 1 clinical trial with the identifier NCT03853109, titled 'AMG 404 in Patients With Advanced Solid Tumors.' This trial was completed and enrolled 171 participants across multiple countries, including the United States, Australia, Belgium, Brazil, Canada, Japan, Poland, Singapore, South Korea, Spain, Taiwan, Turkey, and the United Kingdom.
AMG 404 is a PD-1 inhibitor, but it is a distinct investigational drug developed by Amgen. While it shares the same molecular target as other PD-1 inhibitors, it is not the same as any approved PD-1 inhibitor. The drug is currently in Phase 1 development for advanced solid tumors.