This is an open-label, non-randomized, multicenter, dose-escalation and expansion study in patients with selected solid tumors.
This study will determine the safety, tolerability and activity of CDX-527. Eligible patients that enroll to the dose-escalation portion of the study will be assigned to one of several dose levels of CDX-527. The dose-escalation part of the study will determine the safety profile of CDX-527 and determine which dose(s) of CDX-527 will be studied in the expansion part of the study. The expansion part of the study will enroll eligible patients with certain solid tumors to be treated at dose(s) identified during dose-escalation Up to 40 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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
27
CDX-527 is administered by infusion every 2 weeks
Northside Hospital
Atlanta, Georgia, United States
University of Chicago
Chicago, Illinois, United States
Oncology Hematology West, PC dba Nebraska Cancer Specialists
Omaha, Nebraska, United States
Duke Cancer Center
Durham, North Carolina, United States
Providence Portland Medical Center
Portland, Oregon, United States
Safety and Tolerability of CDX-527 as assessed by CTCAE v5.0
The rates of drug-related adverse events will be summarized and maximum tolerated dose will be determined.
Time frame: From first dose through 28 days after last dose
Objective Response Rate
The percentage of patients who achieve a confirmed immune complete response (iCR) or immune partial response (iPR)
Time frame: Every 8 weeks starting with first dose until disease progression, assessed up to approximately 1-2 years.
Clinical Benefit Rate
The percentage of patients who achieve best response of confirmed iCR or iPR, or immune stable disease (iSD) for at least four months
Time frame: Every 8 weeks, starting with first dose until disease progression, assessed up to approximately 1-2 years.
Duration of Response
The interval from which measurement criteria are first met for iCR or iPR until the first date that progressive disease is objectively documented
Time frame: First occurrence of a documented objective response to disease progression or death (up to approximately 1-2 years)
Progression-free Survival
The time from start of study drug to time of progression or death, whichever occurs first
Time frame: From the first dose to the first occurrence of disease progression or death due to any cause (up to approximately 1-2 years)
Overall Survival
The time from start of study drug to death
Time frame: The time from start of study drug to death from any cause (up to approximately 1-2 years)
Immunogenicity Evaluation
Serum samples will be obtained for assessment of human anti-CDX-527 antibodies
Time frame: Prior to the first dose of study treatment, then intermittently before dosing, and up to 60 days after the last dose
Pharmacokinetic Evaluation
CDX-527 serum concentrations will be measured at specified visits.
Time frame: Before and after dosing, with additional timepoints after the first two doses, then intermittently before dosing and up to 60 days after the last dose
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