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2023-05-11
2025-05-21
2025-05-21
20
NCT05788484
Celldex Therapeutics
Celldex Therapeutics
INTERVENTIONAL
A Study of CDX-585 in Patients With Advanced Malignancies
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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2023-03-15 | N/A | 2025-06-12 |
2023-03-15 | N/A | 2025-06-15 |
2023-03-29 | N/A | 2025-04 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Na
Interventional Model:
Single Group
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: CDX-585 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 ch | DRUG: CDX-585
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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. | 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. | Approximately 6 months |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Safety and Tolerability of CDX-585 as assessed by CTCAE v5.0 | The rates of drug-related adverse events will be summarized and evaluated. | 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) | 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 | 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 | 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 | 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 | 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 | 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 | 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 section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
