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 | 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 |
MEDI0562 is an investigational monoclonal antibody being studied for the treatment of advanced solid tumors. It has been evaluated in clinical trials for patients with selected advanced solid tumors, including those whose cancer has not responded to standard therapies. The drug is administered to adult subjects aged 18 years and older.
MEDI0562 is a monoclonal antibody that targets OX40, a costimulatory receptor expressed on T cells. By engaging OX40, the drug is designed to enhance the immune system's anti-tumor response. This mechanism is being investigated as a potential immunotherapy approach for advanced solid tumors.
MEDI0562 is being developed by AstraZeneca PLC, a multinational pharmaceutical company. AstraZeneca is listed on the stock exchange under the ticker symbol AZN. The company has sponsored clinical trials to evaluate the safety and efficacy of MEDI0562 in patients with advanced solid tumors.
MEDI0562 is in Phase 1 clinical development. It has completed two Phase 1 trials, one evaluating the drug as a monotherapy and another evaluating it in combination with other immune therapeutic agents. The drug is investigational and has not been approved by regulatory authorities for commercial use.
MEDI0562 has been studied in two completed Phase 1 clinical trials. The first trial, NCT02318394, evaluated MEDI0562 as a monotherapy in 56 adults with advanced solid tumors in the United States and South Korea. The second trial, NCT02705482, assessed MEDI0562 in combination with immune therapeutic agents in 58 adults with selected advanced solid tumors in the United States, France, and the Netherlands.
MEDI0562 is a specific OX40 agonist monoclonal antibody developed by AstraZeneca. While it shares a mechanism with other OX40-targeting agents, it is a distinct investigational drug with its own clinical development program. No alternative names for MEDI0562 have been disclosed in the available clinical trial information.