A Phase 1 Dose Escalation Study of MGA271 in Refractory Cancer

Status: Completed
Location: See all (12) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

The purpose of this study is to evaluate the safety of MGA271 when given by intravenous (IV) infusion to patients with refractory cancer. The study will also evaluate how long MGA271 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 may have an effect on tumors.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Histologically or cytologically confirmed carcinoma (prostate cancer, renal cell carcinoma, head and neck cancer, triple-negative breast cancer, bladder cancer, non-small cell lung cancer) or melanoma that overexpresses B7-H3.

• Progressive disease during or after last treatment regimen.

• Appropriate treatment history for histological entity.

• ECOG Performance Status \<= 1.

• Life expectancy \>= 3 months.

• Measurable disease or evaluable disease with relevant tumor marker elevation.

• Acceptable laboratory parameters and adequate organ reserve.

Locations
United States
California
UCLA Hematology-Oncology Clinic
Los Angeles
Connecticut
Yale Cancer Center
New Haven
Florida
Moffitt Cancer Center
Tampa
Illinois
The University of Chicago
Chicago
Kentucky
Norton Cancer Institute
Louisville
Massachusetts
Dana Farber Cancer Institute
Boston
Massachusetts General Hospital Cancer Center
Boston
Neely Center for Clinical Cancer Research, Tufts Medical Center
Boston
Maryland
University of Maryland
Baltimore
North Carolina
Carolina Biooncology Institute
Huntersville
Pennsylvania
Hospital of the University of Pennsylvania/Abramson Cancer Center
Philadelphia
Tennessee
Sarah Cannon Research Institute
Nashville
Time Frame
Start Date: 2011-07
Completion Date: 2019-04-18
Participants
Target number of participants: 179
Treatments
Experimental: MGA271
Fc-optimized, humanized monoclonal antibody
Sponsors
Leads: MacroGenics

This content was sourced from clinicaltrials.gov