Safety Study of MGAH22 in HER2-positive Carcinomas

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2022-06-14

Brief Summary

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The purpose of this study is to determine if MGAH22 is safe when given by intravenous (IV) infusion to patients with HER2-positive cancer. The study will also evaluate how long MGAH22 stays in the blood and how long it takes for it to leave the body, what is the highest dose that can safely be given, and whether it has an effect on tumors.

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Detailed Description

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Conditions

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Breast Cancer Gastric Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Intervention Type BIOLOGICAL

margetuximab

Interventions

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margetuximab

Intervention Type BIOLOGICAL

Other Intervention Names

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MGAH22

Eligibility Criteria

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Inclusion Criteria

* Histologically or cytologically confirmed carcinoma that overexpresses HER2 by immunohistochemistry (2+ or 3+ positivity by HercepTest or equivalent).
* Progressive disease during or after last treatment regimen.
* Appropriate treatment history for histological entity.
* ECOG Performance Status \<= 1.
* Life expectancy \>= 3 month.
* Measurable disease
* Acceptable laboratory parameters and adequate organ reserve.
* Baseline LVEF \>50%

Exclusion Criteria

* Lifetime anthracycline exposure \> 350 mg/m2 of doxorubicin or equivalent
* Major surgery within four weeks before enrollment.
* Known hypersensitivity to murine or recombinant proteins, polysorbate 80, or any excipient contained in the drug formulation.
* Second primary malignancy that has not been in remission for greater than 3 years. Treated non-melanoma skin cancer, cervical carcinoma in situ on biopsy, or squamous intraepithelial lesion on PAP smear, localized prostate cancer (Gleason score \< 6), or resected melanoma in situ are exceptions and do not require a 3 year remission.
* Active viral, bacterial, or systemic fungal infection requiring parenteral treatment within four weeks of enrollment. Patients requiring any oral antiviral, fungal, or bacterial therapy must have completed treatment within one week of enrollment.
* History of chronic or recurrent infections that require continual use of antiviral, antifungal, or antibacterial agents.
* History of deep vein thrombosis, pulmonary embolism, myocardial infarction, or stroke within three months of enrollment.
* Known history of central nervous system (CNS) metastatic disease with evidence of residual or recurrent disease upon entry.
* New York Heart Association class III or IV heart disease.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No