Safety Study of MGAH22 in HER2-positive Carcinomas

MacroGenics

Status and phase

Completed

Phase 1

Conditions

Breast Cancer

Gastric Cancer

Treatments

Biological: margetuximab

Study type

Interventional

Funder types

Industry

NIH

Identifiers

NCT01148849

02598-10 (Other Grant/Funding Number)

CP-MGAH22-01

Details and patient eligibility

About

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.

Enrollment

66 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

66 participants in 8 patient groups

Cohort 1: 0.1 mg/kg weekly for 4 weeks

Experimental group

Description: