Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MEDI0680 · 2 trials · 4 indications
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.
Number of participants in dose-escalation phase with abnormal clinical laboratory parameters reported as TEAEs are reported. Abnormal clinical laboratory parameters are defined as any abnormal finding during analysis of serum chemistry, hematology, coagulation, and urine.
Number of participants in dose-escalation phase with abnormal vital signs reported as TEAEs are reported. Abnormal vital signs is defined as any abnormal finding in the vital sign parameters (blood pressure, heart rate, body temperature, and respiratory rate). Abnormal physical examination findings are defined as any abnormal finding in the following body systems: head and neck, respiratory, cardiovascular, gastrointestinal, urogenital, musculoskeletal, neurological, psychiatric, dermatological, hematologic/lymphatic, and endocrine systems, and weight.
Number of participants in dose-escalation phase with abnormal ECG parameters reported as TEAEs are reported.
The ORR is defined as best overall response of confirmed complete response (CR) or confirmed partial response (PR) based on RECIST v1.1. The CR is defined as disappearance of all target and non-target lesions and no new lesions. The PR is defined as \>= 30% decrease in the sum of diameters of target lesions (compared to baseline) and no new non-target lesion. A confirmed CR or PR is defined as 2 CRs or 2 PRs that were separated by at least 4 weeks with no evidence of progression in-between.
The primary objectives are to assess the safety and tolerability of multiple doses of MEDI0680 (AMP-514) and define the maximum tolerated dose (MTD) or highest protocol-defined dose of MEDI0680 (AMP-514) in the absence of exceeding the MTD.
| Arm | Type | Description |
|---|---|---|
| MEDI0680 0.1 mg/kg + Durvalumab 3 mg/kg | EXPERIMENTAL | Participants in dose-escalation phase will receive IV infusion of MEDI0680 0.1 mg/kg and durvalumab 3 mg/kg every 2 weeks (Q2W) for up to 12 months. |
| MEDI0680 0.1 mg/kg + Durvalumab 10 mg | EXPERIMENTAL | Participants in dose-escalation phase will receive IV infusion of MEDI0680 0.1 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months. |
| MEDI0680 0.5 mg/kg + Durvalumab 10 mg | EXPERIMENTAL | Participants in dose-escalation phase will receive IV infusion of MEDI0680 0.5 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months. |
| MEDI0680 2.5 mg/kg + Durvalumab 10 mg | EXPERIMENTAL | Participants in dose-escalation phase will receive IV infusion of MEDI0680 2.5 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months. |
| MEDI0680 10 mg/kg + Durvalumab 10 mg | EXPERIMENTAL | Participants in dose-escalation phase will receive IV infusion of MEDI0680 10 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months. |
| MEDI0680 20 mg/kg + Durvalumab 10 mg | EXPERIMENTAL | Participants in dose-escalation phase will receive IV infusion of MEDI0680 20 mg/kg and durvalumab 10 mg/kg Q2W for up to 12 months. |
| MEDI0680 20 mg/kg | EXPERIMENTAL | Participants in dose-expansion phase will receive IV infusion of MEDI0680 20 mg/kg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first. |
| MEDI0680 20 mg/kg + Durvalumab 750 mg | EXPERIMENTAL | Participants in dose-expansion phase will receive IV infusion of MEDI0680 20 mg/kg and durvalumab 750 mg/kg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first. |
| Nivolumab 240 mg | ACTIVE_COMPARATOR | Participants in dose-expansion phase will receive IV infusion of nivolumab 240 mg Q2W until unacceptable toxicity, confirmed disease progression, development of other reason for treatment discontinuation, or for a maximum of 2 years, whichever occurred first. |
| Dose arms | EXPERIMENTAL | Dose Escalation |
| Name | Type | Description |
|---|---|---|
| MEDI0680 | BIOLOGICAL | Participants will receive IV infusion of MEDI0680 0.1 or 0.5 or 2.5 or 10 or 20 mg/kg Q2W in dose-escalation phase and 20 mg/kg Q2W in dose-expansion phase. |
| Durvalumab | BIOLOGICAL | Participants will receive IV infusion of durvalumab 3 and 10 mg Q2W in dose-escalation phase and 750 mg Q2W in dose-expansion phase. |
| Nivolumab | BIOLOGICAL | Participants will receive IV infusion of nivolumab 240 mg Q2W in dose-expansion phase. |
| MEDI0680 (AMP-514) | DRUG | Study has planned dose escalation cohorts |
Inclusion Criteria: * Must be 18 years or older * Eastern Cooperative Oncology Group performance status of 0-1 * Adequate organ function * At least 1 prior line of therapy Exclusion Criteria: * Concurrent enrollment in another clinical study, unless in follow-up period or it is an observational s...
MEDI0680 is an investigational small molecule being studied for the treatment of advanced malignancies, including select advanced malignancies such as kidney cancer and clear cell renal cell carcinoma. It is in Phase 1 clinical development and is not yet approved by regulatory authorities.
MEDI0680 is a small molecule designed to target a specific molecular pathway involved in cancer. However, the exact molecular target has not been disclosed in the available information. It is being evaluated for its safety and antitumor activity in patients with advanced solid tumors.
MEDI0680 is being developed by AstraZeneca PLC, a multinational pharmaceutical company listed on the stock exchange under the ticker symbol AZN. The drug is currently in Phase 1 clinical trials for the treatment of advanced malignancies.
MEDI0680 is in Phase 1 clinical development. It has completed two Phase 1 trials, one as a monotherapy and one in combination with durvalumab. The drug is investigational and has not received FDA approval for any indication.
MEDI0680 has been studied in two completed clinical trials. The first, NCT02013804, was a Phase 1 study evaluating safety, tolerability, and pharmacokinetics in patients with advanced malignancies. The second, NCT02118337, was a Phase 1/2 study of MEDI0680 in combination with durvalumab versus nivolumab monotherapy in select advanced malignancies.
Yes, MEDI0680 is also known as AMP-514. Both names refer to the same investigational drug developed by AstraZeneca. In clinical trials, it has been referred to as MEDI0680 (AMP-514) to indicate the alternative name.