Last updated on February 2020

A Study of CDX-1140 as Monotherapy or in Combination in Patients With Advanced Malignancies


Brief description of study

This is a study to determine the maximum tolerated dose (MTD) for CDX-1140, either alone or in combination with CDX-301 or pembrolizumab, and to further evaluate its tolerability and efficacy in expansion cohorts once the MTD is determined.

Detailed Study Description

This study will determine the MTD of CDX-1140 while also evaluating the safety, tolerability and efficacy of CDX-1140 alone (Part 1) or in combination with CDX-301 (Part 2) or pembrolizumab (Part 3) 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 or pembrolizumab, 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, and up to 40 patients will be enrolled for CDX-1140 in combination with pembrolizumab.

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.

Clinical Study Identifier: NCT03329950

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