A Phase I Study of MGAH22 in Patients With Refractory HER2 Positive Cancers
- MGAH22 is an experimental drug that has been designed to target cancer cells that make too much of a protein called human epidermal growth factor receptor 2 (HER2). Too much of this protein can turn a normal cell into a cancer cell and cause the cancer to grow faster. Some treatments have been successful at targeting HER2-positive cancer cells, particularly HER2-positive breast cancer, but these treatments have not been as effective for other types of HER2-positive cancers. MGAH22 is being tested to see if it is a safe and effective potential treatment for HER2-positive cancers that have not responded to standard treatments.
- To evaluate the safety and effectiveness of MGAH22 in treating HER2-positive cancers that have not responded to standard treatments.
- Individuals at least 18 years of age who have been diagnosed with HER2-positive breast cancer or other HER2-positive cancers (such as bladder, ovarian, lung, and prostate cancer) that have not responded to standard treatments.
- Participants will be screened with a physical examination, medical history, blood tests to evaluate current HER2 levels, imaging studies, and an electrocardiogram (ECG) to evaluate heart function.
- Participants must have stopped treatment with surgery, radiation, chemotherapy, and other test drugs at least 4 weeks before the start of this study. Treatment with monoclonal antibodies must have stopped about 3 months before the start of the study.
- This study will last at least 11 weeks, with about 13 office visits to the study doctor. The duration of the study will depend on the participant s response and benefit to the therapy.
- Participants will receive one dose of MGAH22 once a week for 4 weeks (a 28-day cycle of treatment). Blood samples will be taken on days 1, 2, 4, 5, 8, 15, and 22; urine samples will be taken on days 1 and 22. An echocardiogram will be performed on days 8, 15, and 22.
- Participants will have follow-up visits on days 29, 36, 43, and 50. Participants will be asked about side effects, provide blood samples (days 36, 43, and 50), have an imaging scan and ECG to evaluate tumor size and heart function (day 43), and have a physical exam (day 50).
- Participants who respond to the treatment and have no serious side effects may be eligible to continue taking the drug.
Non-Small Cell Lung Neoplasms
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase 1, Dose Escalation Study of MGAH22 (Fc-Optimized Chimeric Anti-HER2 Monoclonal Antibody) in Patients With Refractory HER2 Positive Breast Cancer and Patients With Other HER2 Positive Carcinomas for Whom no Standard Therapy is Available|
- To determine the toxicity profile of four once-weekly intravenous (IV) doses of MGAH22.
- To determine the MTD, PK, and immunogenicity of 4 once-weekly IV doses of MGAH22; to describe any preliminary evidence of anti-tumor activity; and to evaluate the safety, definitive PK, immunogenicity, and preliminary efficacy at the MTD dose/sc...
|Study Start Date:||August 2010|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Udayan Guha, M.D.||National Cancer Institute (NCI)|