A Phase I Study of MGAH22 in Patients With Refractory HER2 Positive Cancers
|First Received Date ICMJE||September 3, 2010|
|Last Updated Date||November 27, 2013|
|Start Date ICMJE||August 2010|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||To determine the toxicity profile of four once-weekly intravenous (IV) doses of MGAH22.|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT01195935 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
||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...|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||A Phase I Study of MGAH22 in Patients With Refractory HER2 Positive Cancers|
|Official Title ICMJE||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|
- 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.
Because the higher affinity alleles of CD16A and CD32A are less frequent in the population than the lower affinity alleles, these observations suggest that anti-HER2 antibodies, such as MGAH22, engineered to have increased affinity for the activating Fc receptors and in particular the low binding alleles of the activating Fc receptors may have increased clinical activity and should be pursued.
-To determine the toxicity profile of four once-weekly intravenous (IV) doses of MGAH22.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 1|
|Study Design ICMJE||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Intervention ICMJE||Drug: MGAH22
|Study Arm (s)||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Active, not recruiting|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
-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.
|Ages||18 Years and older|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT01195935|
|Other Study ID Numbers ICMJE||100189, 10-C-0189|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||National Cancer Institute (NCI)|
|Collaborators ICMJE||Not Provided|
|Information Provided By||National Institutes of Health Clinical Center (CC)|
|Verification Date||February 2013|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP