Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AMG 650 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Dose Exploration Phase | EXPERIMENTAL | Participants will receive AMG 650 in 1 of 3 alternative schedules. The maximum tolerated dose (MTD) of each schedule will be estimated using isotonic regression (Ji et al, 2010). The Recommended Phase 2 Dose (RP2D) may be identified based on emerging safety, efficacy, and pharmacodynamics (PD) data prior to reaching an MTD. |
| Dose Expansion Phase Group 1: TNBC | EXPERIMENTAL | Participants with locally advanced or metastatic triple negative breast cancer (TNBC), will be administered with the preliminary RP2D identified from the dose exploration part of the study. |
| Dose Expansion Phase Group 2: HGSOC | EXPERIMENTAL | Participants with locally advanced or metastatic high grade serous ovarian cancer (HGSOC), will be administered with the preliminary RP2D identified from the dose exploration part of the study. |
| Name | Type | Description |
|---|---|---|
| AMG 650 | DRUG | AMG 650 administered orally as a tablet. |
Inclusion Criteria: * Male and female ≥ 18 years old * Triple Negative Breast Cancer participants only: Participant must have histologically or cytologically confirmed metastatic or locally recurrent estrogen receptor (ER)-negative (\<1% by immunohistochemistry \[IHC\]), progesterone receptor (PR)-...
| 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 650 is an investigational small molecule being studied for the treatment of advanced solid tumors. It is currently in Phase 1 clinical development, meaning it has not yet been approved by regulatory authorities and remains under investigation for safety and efficacy in patients.
AMG 650 is being developed by Amgen Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol AMGN. The company is conducting clinical research to evaluate the drug's potential in treating advanced solid tumors.
AMG 650 is in Phase 1 clinical development. It is an investigational drug, not yet approved by the FDA or other regulatory agencies. The Phase 1 trial has been completed, and the drug is still in the early stages of clinical evaluation for advanced solid tumors.
AMG 650 has one completed Phase 1 clinical trial, identified as NCT04293094, titled 'Study of AMG 650 in Adult Participants With Advanced Solid Tumors.' The trial enrolled 66 participants across multiple countries, including the United States, Australia, Belgium, Canada, Italy, Japan, and Spain.
AMG 650 is the primary name for this investigational drug. No alternative names have been reported in the clinical trial information. It is a small molecule being developed by Amgen for the treatment of advanced solid tumors.