Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MEDI0562 · 2 trials · 2 indications
The primary endpoint is safety as assessed by presence of adverse event (AE), serious adverse event (SAE), and dose limiting toxicity (DLT).
The maximum tolerated dose/maximum administered dose will be determined by the number of participants experiencing DLTs. The safety profile will be assessed through number of participants experiencing AEs, SAEs, abnormal laboratory parameters, vital signs and electrocardiogram (ECG) results.
| Arm | Type | Description |
|---|---|---|
| Arm A: MEDI0562 and durvalumab | EXPERIMENTAL | MEDI0562 and durvalumab |
| Arm B: MEDI0562 and tremelimumab | EXPERIMENTAL | MEDI0562 and tremelimumab |
| Monotherapy Arm | EXPERIMENTAL | MEDI0562 monotherapy |
| Name | Type | Description |
|---|---|---|
| MEDI0562 | BIOLOGICAL | Subjects will remain on treatment until unacceptable toxicity, documentation of progressive disease (PD), or development of other reason for treatment discontinuation. |
| Tremelimumab | BIOLOGICAL | Subjects will remain on treatment until unacceptable toxicity, documentation of progressive disease (PD), or development of other reason for treatment discontinuation. |
| Durvalumab | BIOLOGICAL | Subjects will remain on treatment until unacceptable toxicity, documentation of progressive disease (PD), or development of other reason for treatment discontinuation. |
Inclusion Criteria: Subjects must meet all of the following criteria: 1. Written and signed informed consent. 2. Age ≥ 18 years at the time of study entry. 3. Subjects must have received and have progressed, are refractory, or are intolerant to standard therapy appropriate for the specific tumor t...
| 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 |
MEDI0562 is an investigational monoclonal antibody being studied for the treatment of advanced solid tumors, including select advanced solid tumors. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
MEDI0562 is a monoclonal antibody, but its specific molecular target has not been disclosed in available information. The drug is being evaluated in oncology for advanced solid tumors, though its mechanism of action is not publicly detailed.
MEDI0562 is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker symbol AZN. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with advanced solid tumors.
MEDI0562 is in Phase 1 clinical development. It is an investigational drug, meaning it has not yet received regulatory approval and is still being studied in clinical trials to assess its safety and potential effectiveness in treating advanced solid tumors.
MEDI0562 has been studied in two Phase 1 clinical trials. The first, NCT02318394, evaluated the drug alone in adults with advanced solid tumors. The second, NCT02705482, assessed MEDI0562 in combination with other immune therapeutic agents in adults with select advanced solid tumors. Both trials are completed.