Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as MEDI0680 (AMP-514), AMP-514
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 oncology drug developed by AstraZeneca PLC (ticker AZN) for advanced malignancies. It has been studied in Phase 1 clinical trials, including in combination with durvalumab and compared with nivolumab monotherapy in select advanced malignancies such as clear cell renal cell carcinoma.
MEDI0680 has been studied in adults with advanced malignancies, including select advanced malignancies and clear cell renal cell carcinoma. It was evaluated in an open-label Phase 1/2 study combining it with durvalumab versus nivolumab monotherapy, and in a separate Phase 1 study of safety, tolerability and pharmacokinetics in advanced malignancies.
MEDI0680 is developed by AstraZeneca PLC, which trades under the ticker AZN. The drug is also referred to in study records as AMP-514.
MEDI0680 is in Phase 1 development. It is investigational and has been evaluated in early-stage clinical trials in patients with advanced malignancies, including a Phase 1/2 combination study and a Phase 1 safety, tolerability and pharmacokinetic study.
MEDI0680 has been studied in two completed trials: NCT02118337, a Phase 1/2 open-label study of MEDI0680 plus durvalumab versus nivolumab monotherapy in select advanced malignancies, and NCT02013804, a Phase 1 study of safety, tolerability and pharmacokinetics in advanced malignancies.
Yes. MEDI0680 is also known as AMP-514, and study records list it as MEDI0680 (AMP-514). Other recorded name variants include MEDI0680 2.5 mg/kg and MEDI0680/kg, which refer to the same investigational agent developed by AstraZeneca PLC.