A Phase 1, Open-label, Dose-escalation, Safety and Pharmacokinetic Study of CDX-1127 in Patients With Selected Refractory or Relapsed Hematologic Malignancies or Solid Tumors
CDX-1127 is a fully human monoclonal antibody that binds to a molecule called CD27 found on
certain immune cells and also on certain hematologic tumor cells and may act to promote
This study will evaluate the safety and activity of escalating doses of CDX-1127 in patients
with B-cell hematologic malignancies known to express CD27 and solid tumors that are more
likely to be responsive to the immune system.
Eligible patients who enroll in the study will be assigned to one of 5 dose levels of
CDX-1127. The first phase of the study will test the safety profile of CDX-1127 and will
assess which dose to test in future studies.
During the second phase, cohorts of approximately 15 patients each will receive the study
treatment to continue to evaluate the safety profile of CDX-1127 and to determine if it has
an effect on their cancer. Expansion cohorts may be limited to one or more tumor types.
Patients enrolled in the study may receive study treatment for up to 5 cycles, until their
disease has progressed or until it is necessary to stop the treatment for safety or other
All patients enrolled in the study will be closely monitored to determine if their cancer is
responding to treatment and for any side effects that may occur.
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Characterize the adverse events associated with CDX-1127 administration
Analysis of adverse events along with the results of vital sign measurements, physical examinations, and clinical laboratory tests will be used to determine the safety profile of CDX-1127.
Until day 70 follow up.
United States: Food and Drug Administration
|Mayo Clinic||Rochester, Minnesota 55905|
|University of Virginia Health System||Charlottesville, Virginia 22903|
|Sarah Cannon Research Institute||Nashville, Tennessee 37203|
|Mary Crowley Cancer Research Centers - Medical City||Dallas, Texas 75201|
|The Ohio State University Comprehensive Cancer Center||Columbus, Ohio 43210|
|Mayo Clinic Arizona - Cancer Clinical Research Unit||Scottsdale, Arizona 85259|
|Stanford Cancer Center - Stanford University||Stanford, California 94305|