A Phase 1 interventional study of CDX-585 in Non-small Cell Lung Cancer, Gastric Cancer and Head and Neck Cancer, sponsored by Celldex Therapeutics. Completed at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-15.
Sponsored by Celldex Therapeutics · Phase 1, Interventional, and Treatment
This is an open-label, non-randomized, multicenter, dose-escalation and expansion study in patients with selected solid tumors.
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.
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.
6,745 studies on the registry are indexed under Carcinoma; 1,163 are open to participants now.
This study's enrollment of 20 is below the median of 45 across 5,174 interventional studies indexed under Carcinoma.
Browse Carcinoma studies →Celldex Therapeutics is the lead sponsor of 43 studies on the registry; 3 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 1 (7%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
There are additional criteria your study doctor will review with you to confirm eligibility.
Dose-escalation phase: Eligible patients will receive treatment, based on cohort assigned, in 2-week cycles until progression or intolerance. Expansion phase: Patients enrolled in the expansion phase of the study will receive CDX-585 at the dose level chosen during the escalation phase.
Drug: CDX-585
CDX-585 is administered by infusion every 2 weeks
Dose escalation: To determine the maximum tolerated dose of CDX-585 and to select the CDX-585 dose(s) for evaluation in tumor-specific expansion cohorts
The rates of drug-related adverse events will be summarized, and maximum tolerated dose will be determined.
Time frame: Approximately 12 months
Tumor-specific expansion cohorts: To further evaluate the safety of CDX-585 by tumor type.
The rates of drug-related adverse events will be summarized, and further evaluated in specific tumor types.
Time frame: Approximately 6 months
Safety and Tolerability of CDX-585 as assessed by CTCAE v5.0
The rates of drug-related adverse events will be summarized and evaluated.
Time frame: From first dose through 90 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: Assessed up to approximately 1-3 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: Assessed up to approximately 1-3 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 1-3 years)
Progression-free Survival
The time from start of study drug to time of progression or death, whichever occurs first
Time frame: Cycle 1, day 1 to the first occurrence of disease progression or death due to any cause (up to approximately 1-3 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 1-3 years)
Pharmacokinetic Evaluation
CDX-585 serum concentrations will be measured at specified visits
Time frame: Prior to, during, and at multiple time points after doses 1-4. Prior to every other dose from fifth dose, and at 30 and 90 days post last dose of study treatment
Immunogenicity Evaluation
Samples will be obtained for assessment of human anti-CDX-585
Time frame: Prior to the first three doses and every other dose from the fifth dose of study treatment, then 30 and 90 days after the last dose
This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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Celldex Therapeutics