A Phase 1 Study of CDX-1140 as Monotherapy or in Combination in Patients With Advanced Malignancies
Head and Neck Cancer
18 Years and older, Male and Female
This is a study to determine the maximum tolerated dose (MTD) for CDX-1140, either alone or in combination with CDX-301, and to further evaluate its tolerability and efficacy in expansion cohorts once the MTD is determined.
CDX-1140 is a fully human monoclonal antibody that binds to a cell receptor called CD40
expressed on certain cells and which activates the immune system, which then may promote
anti-tumor effects in patients with cancer. CD40 is also expressed on some types of cancer
cells and CDX-1140 may directly cause those cells to die.
CDX-301 is a growth factor for dendritic cells, a key cell type that regulates immune
responses, including anti-tumor immune responses.
This study will determine the MTD of CDX-1140 while also evaluating the safety, tolerability
and efficacy of CDX-1140 in patients with cancer.
Eligible patients that enroll to the dose-escalation portion of the study will be assigned to
one of several dose levels of CDX-1140. The dose-escalation part of the study will test the
safety profile of CDX-1140, alone or in combination with CDX-301, and determine which dose(s)
of CDX-1140 will be studied in the expansion portions of the study.
Up to 140 patients will be enrolled for CDX-1140 monotherapy. Up to 40 patients will be
enrolled for CDX-1140 in combination with CDX-301.
All patients enrolled in the study will be closely monitored to determine if there is a
response to the treatment as well as for any side effects that may occur.
Treatment Sites in Georgia