A Phase I Study of MGAH22 in Patients With Refractory HER2 Positive Cancers

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT01195935
First received: September 3, 2010
Last updated: March 14, 2014
Last verified: December 2013
  Purpose

Background:

- 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.

Objectives:

- To evaluate the safety and effectiveness of MGAH22 in treating HER2-positive cancers that have not responded to standard treatments.

Eligibility:

- 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.

Design:

  • 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.

Condition Intervention Phase
Non-Small Cell Lung Neoplasms
Prostate Neoplasms
Bladder Neoplasms
Ovarian Neoplasms
Breast Neoplasms
Drug: MGAH22
Phase 1

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • To determine the toxicity profile of four once-weekly intravenous (IV) doses of MGAH22.

Secondary Outcome Measures:
  • 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...

Enrollment: 20
Study Start Date: August 2010
Intervention Details:
    Drug: MGAH22
    N/A
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:
  • Patients of all races and ethnic origins will be eligible.
  • Both men and women and members of all races and ethnic groups are eligible for this trial.
  • Histologically or cytologically confirmed carcinoma that overexpresses HER2 byimmunohistochemistry (2+ or 3+ positivity by HercepTest or equivalent).
  • Progressive disease during or after last treatment regimen.
  • Appropriate treatment history for histological entity.

EXCLUSION CRITERIA:

-Participants under the age of 18 will be excluded from the study because adverse event data are not available for this age group with this therapy.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01195935

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
Investigators
Principal Investigator: Udayan Guha, M.D. National Cancer Institute (NCI)
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT01195935     History of Changes
Other Study ID Numbers: 100189, 10-C-0189
Study First Received: September 3, 2010
Last Updated: March 14, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Pharmacokinetics
Immunogenicity
Fc Receptor
Monoclonal Antibody
HER2 Overexpression
Breast Cancer
Prostate Cancer
Ovarian Cancer
Bladder Cancer
Non-Small Cell Lung Cancer

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Breast Neoplasms
Neoplasms
Lung Neoplasms
Ovarian Neoplasms
Prostatic Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Urinary Bladder Diseases
Urologic Diseases
Breast Diseases
Skin Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Endocrine Gland Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Endocrine System Diseases
Gonadal Disorders
Genital Neoplasms, Male
Genital Diseases, Male
Prostatic Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 20, 2014