Status and phase
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About
This is an open-label, non-randomized, multicenter, dose-escalation and expansion study in patients with selected solid tumors.
Full description
This study will determine the maximum tolerated dose of CDX-585 while also evaluating the safety, tolerability, and efficacy of CDX-585 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-585. The dose-escalation part of the study will test the safety profile of CDX-585 and determine which dose of CDX-585 will be studied in the expansion portions of the study.
Approximately 130 patients will be enrolled. 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.
The expansion portion of the study will further evaluate the safety of CDX-585 in selected tumor types at the dose level chosen during the escalation part of the study.
Enrollment
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Inclusion and exclusion criteria
Key Inclusion Criteria:
Key Exclusion Criteria:
There are additional criteria your study doctor will review with you to confirm eligibility.
Primary purpose
Allocation
Interventional model
Masking
130 participants in 1 patient group
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Central trial contact
Celldex Therapeutics
Data sourced from clinicaltrials.gov
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