Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AMG 994 · 1 trial · 1 indication
DLTs were defined as: * Grade 5 events * Grade 4 neutropenia/thrombocytopenia of any duration * Grade 3 thrombocytopenia w/ clin significant bleeding or lasting \>7 days * Febrile neutropenia * Grade 4 anemia * Grade 3/4 non-hematologic toxicity, except: Grade 3 nausea/vomiting or diarrhea \< 72 hours; Grade 3 fatigue \< 1 week; Asymptomatic grade 3 electrolyte abnormalities that last \< 72 hours, are not clinically complicated, and resolve spontaneously or respond to conventional medical interventions; Grade 3 amylase/ lipase elevations; Other laboratory parameters of grade 3, not considered clinically relevant and improved to grade ≤ 2 within 72 hours. * Any grade 3 event requiring hospitalization * Recurrent grade 2 pneumonitis * Delay in cycle 2 treatment for \> 14 days due to an adverse event in the dose escalation portion of the study * Any event requiring discontinuation of AMG 994
TEAEs were those that occurred after the first intervention dose. A serious adverse event (SAE) included outcomes such as death, life-threatening situations, hospitalization or an extended hospital stay, significant incapacity, congenital defects, or other crucial medical events. AE severity followed the CTCAE Version 5.0 scale: grade 1 (mild), grade 2 (moderate), grade 3 (severe), grade 4 (life-threatening), and grade 5 (death). Clinically significant laboratory results or other assessments (e.g., ECGs, scans, vital signs) that worsened from baseline and were deemed important by the investigator, independent of disease progression, were also considered.
| Arm | Type | Description |
|---|---|---|
| Part 1a: Dose Exploration | EXPERIMENTAL | Determine the maximum tolerated dose (MTD) or the recommended phase 2 dose (RP2D) of AMG 994, in combination with AMG 404. |
| Part 1b: Dose Exploration | EXPERIMENTAL | Determine the maximum tolerated dose (MTD) or the recommended phase 2 dose (RP2D) of AMG 994, in combination with AMG 404. |
| Part 1c: Dose Exploration | EXPERIMENTAL | Determine the maximum tolerated dose (MTD) or the recommended phase 2 dose (RP2D) of AMG 994, in combination with AMG 404. |
| Part 2: Dose Expansion | EXPERIMENTAL | Participants will be administered with the MTD or RP2D of AMG 994 identified in the dose escalation part of the study, in combination with AMG 404. |
| Name | Type | Description |
|---|---|---|
| AMG 994 | DRUG | Administered as an intravenous (IV) infusion. |
| AMG 404 | DRUG | Administered as an intravenous (IV) infusion. |
Inclusion Criteria: * Participant has provided informed consent/assent prior to initiation of any study specific activities/procedures. * Age ≥ 18 years at the time of signing informed consent. * Life expectancy of \> 3 months, in the opinion of the investigator. * Participant must have histologica...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 3 | PHASE2 | Pembrolizumab, Gardasil 9 |
| Incyte Corporation | INCY | 1 | PHASE2 | Retifanlimab |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115 |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | Aldesleukin |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
AMG 994 is an investigational therapy being studied for the treatment of advanced solid tumors. It is a small molecule developed by Amgen Inc. and is currently in Phase 1 clinical development. The single completed trial enrolled 11 participants with advanced solid tumors across multiple countries.
AMG 994 is being developed by Amgen Inc., a biotechnology company whose common stock trades on Nasdaq under the ticker symbol AMGN. Amgen is the sponsor of the clinical program evaluating AMG 994 in advanced solid tumors.
AMG 994 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. The study enrolled 11 participants and evaluated AMG 994 as a monotherapy and in combination with AMG 404 in advanced solid tumors.
AMG 994 has been evaluated in one Phase 1 clinical trial, NCT04727554, titled "Study of AMG 994 Monotherapy and AMG 994 and AMG 404 Combination Therapy in Participants With Advanced Solid Tumors." The trial is completed and enrolled 11 participants across the United States, Australia, Belgium, Canada, France, Germany, Japan, Poland, Spain, and the United Kingdom.
Yes, the AMG 994 Phase 1 trial NCT04727554 was biomarker-selected, meaning participants were enrolled based on specific biomarker criteria. The study evaluated AMG 994 as a monotherapy and in combination with AMG 404 in adults with advanced solid tumors.