Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AMG 305 · 1 trial · 1 indication
Adverse events (AEs) are defined as any untoward medical occurrence in a clinical study participant irrespective of a causal relationship with the study treatment. TEAEs are any event that occurs after the participant has received study treatment. Any clinically significant changes in vital signs, electrocardiograms (ECGs), and clinical laboratory tests, as assessed by the investigator, will also be reported as TEAEs.
| Arm | Type | Description |
|---|---|---|
| Part A: Dose Exploration | EXPERIMENTAL | Participants will receive escalating doses of AMG 305. |
| Part B: Dose Expansion | EXPERIMENTAL | Participants with selected solid tumors will receive the RP2D identified in Part A. |
| Name | Type | Description |
|---|---|---|
| AMG 305 | DRUG | Short-term intravenous (IV) infusion |
Key Inclusion Criteria: * Participant has provided informed consent to the main study prior to initiation of any study specific activities/procedures * Male or female participants age ≥ 18 years * Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 * Participants with histologica...
| 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 305 is an investigational small molecule being developed for the treatment of advanced solid tumors. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities. The drug is being studied to evaluate its safety, tolerability, and pharmacokinetics in patients with advanced solid tumors.
AMG 305 is being developed by Amgen Inc., a biotechnology 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 305 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency. The Phase 1 trial has been completed, and the drug remains in early-stage clinical research for advanced solid tumors.
AMG 305 has one completed Phase 1 clinical trial registered as NCT05800964. This study explored the safety, tolerability, and pharmacokinetics of AMG 305 in subjects with advanced solid tumors. The trial enrolled 37 participants across multiple countries, including the United States, Australia, Canada, France, Germany, Japan, South Korea, Spain, and the United Kingdom.
No alternative names for AMG 305 have been disclosed. The drug is identified solely by its development code AMG 305 and is being studied under this name in clinical trials. It is not known to be marketed under any other brand name.