HER2 Expressing Breast or Gastric/Stomach Cancers
Conditions
Brief summary
This research study is designed to evaluate an experimental drug, MEDI4276, in treating breast and stomach (gastric) cancer.
Interventions
BIOLOGICALMEDI4276
MEDI4276 is an investigational product
Sponsors
MedImmune LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 18 years. 2. Histologically or cytologically documented unresectable, locally advanced or metastatic breast cancer or gastric cancer refractory to standard therapy. 1. For subjects with breast cancer: * Prior treatment with trastuzumab, pertuzumab, and T-DM1, either alone or in combination, is required. * Subjects with a primary tumor that is hormone (estrogen, progesterone, or both) receptor-positive or receptor-negative are eligible. * Prior hormone therapy is allowed, but last dose must be at least 14 days prior to first dose of MEDI4276. 2. For subjects with gastric cancer: * Prior treatment with a trastuzumab containing chemotherapy regimen is required. 3. HER2 Positive disease documented as FISH-positive and/or 3+ by IHC on previously collected tumor tissue. 4. At least one lesion measurable by RECIST Version 1.1.
Exclusion criteria
1. Receipt of any conventional or investigational anticancer treatment within 28 days prior to the first dose of MEDI4276. 2. History of exposure to the following cumulative doses of anthracyclines: 1. Doxorubicin or liposomal doxorubicin \>350 mg/m². 2. Epirubicin \>530 mg/m². 3. Mitoxantrone \>90 mg/m² and idarubicin \> 70 mg/m². 4. If another anthracycline or more than 1 anthracycline has been used, then the cumulative dose must not exceed the equivalent of 350 mg/m² of doxorubicin. 3. Known brain metastases that are untreated, symptomatic, or require therapy to control symptoms; or any radiation, surgery or other therapy to control symptoms from brain metastases within 2 months prior to first dose of MEDI4276.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number and percentage of subjects with adverse events (AEs), serious adverse events (SAEs) and dose-limiting (DLTs). | From Time of informed consent through 90 days after last dose of MEDI4276 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (ORR) | Time from Informed Consent up to 3 years | The ORR is defined as the proportion of subjects with confirmed CR or confirmed PR |
| Peak Plasma Concentration (Cmax) | From first dose of MEDI4276 thorugh to 30 days after last dose of investigational product | The immunogenicity of MEDI4276 will be assessed by summarizing the number and percentage of subjects who develop detectable anti-drug antibodies (ADAs) |
| Progression-free survival (PFS) | Estimated to be from time of informed consent up to 3 years | 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. |
| Overall survival (OS) | Estimated to be from time of informed consent up to 3 years | Overall survival will be determined as the time from the start of treatment with MEDI4276 until death due to any cause. |
| Area under the plasma concentration versus time curve (AUC) | From first dose of MEDI4276 through to 30 days after the last dose of investigational product | The immunogencity of MEDI 4276 will be assessed by summarizing the number and percentage of subjects who develop detectable anti-drug antibodies (ADAs). |
Countries
United States
Outcome results
None listed