This research study is designed to evaluate an experimental drug, MEDI4276, in treating breast and stomach (gastric) cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
47
MEDI4276 is an investigational product
Research Site
Stanford, California, United States
Research Site
Sarasota, Florida, United States
Research Site
Indianapolis, Indiana, United States
Research Site
Charlotte, North Carolina, United States
Number and percentage of subjects with adverse events (AEs), serious adverse events (SAEs) and dose-limiting (DLTs).
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.
Time frame: From Time of informed consent through 90 days after last dose of MEDI4276
Objective Response Rate (ORR)
The ORR is defined as the proportion of subjects with confirmed CR or confirmed PR
Time frame: Time from Informed Consent up to 3 years
Peak Plasma Concentration (Cmax)
The immunogenicity of MEDI4276 will be assessed by summarizing the number and percentage of subjects who develop detectable anti-drug antibodies (ADAs)
Time frame: From first dose of MEDI4276 thorugh to 30 days after last dose of investigational product
Progression-free survival (PFS)
Progression-free survival will be measured from the start of treatment with MEDI4276 until the first documentation of confirmed immune-related disease progression or death due to any cause, whichever occurs first.
Time frame: Estimated to be from time of informed consent up to 3 years
Overall survival (OS)
Overall survival will be determined as the time from the start of treatment with MEDI4276 until death due to any cause.
Time frame: Estimated to be from time of informed consent up to 3 years
Area under the plasma concentration versus time curve (AUC)
The immunogencity of MEDI 4276 will be assessed by summarizing the number and percentage of subjects who develop detectable anti-drug antibodies (ADAs).
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Research Site
Nashville, Tennessee, United States
Time frame: From first dose of MEDI4276 through to 30 days after the last dose of investigational product