A Study of CDX-585 in Patients With Advanced Malignancies

June 12, 2025 updated by: Celldex Therapeutics

A Phase 1 Dose-escalation and Expansion Study of the PD-1 x ILT4 Bispecific Antibody 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20037
        • George Washington University Cancer Center
    • Florida
      • Celebration, Florida, United States, 34747
        • AdventHealth Celebration
    • New York
      • New York, New York, United States, 10016
        • Perlmutter Cancer Center at NYU Langone Health
    • Oregon
      • Portland, Oregon, United States, 97213
        • Providence Cancer Institute

Participation Criteria

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

  1. Recurrent, locally advanced, or metastatic solid tumor cancer excluding primary central nervous system tumors (e.g., glioblastoma).
  2. Receipt of standard therapy for the tumor type in the recurrent, locally advanced, or metastatic setting.
  3. Measurable (target) disease by iRECIST.
  4. If of childbearing potential (male or female), agrees to practice an effective form of contraception during study treatment and for at least 3 months following last treatment.
  5. Willingness to undergo a pre-treatment and on-treatment biopsy, if required.

Key Exclusion Criteria:

  1. History of severe hypersensitivity reactions to other monoclonal antibodies.
  2. Previous treatment with any anti-ILT4 antibody.
  3. Patients who have received more than 1 anti-PD-1 or anti-PD-L1 targeted therapy, including in the adjuvant setting.
  4. Prior anti-PD-L1 based therapy within 12 weeks and prior anti-PD-1 based therapy within four weeks to the planned start of study treatment.
  5. Other prior malignancy, except for adequately treated basal or squamous cell skin cancer or in situ cancers. For all other cancers, the patient must be disease-free for at least one year to be allowed to enroll.
  6. Thrombotic events within the last six months prior to study treatment
  7. Active, untreated central nervous system metastases.
  8. Active autoimmune disease or documented history of autoimmune disease.
  9. History of (non-infectious) pneumonitis or has current pneumonitis.

There are additional criteria your study doctor will review with you to confirm eligibility.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

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 chosen during the escalation phase.
Drug: CDX-585
CDX-585 is administered by infusion every 2 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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
Time Frame: Approximately 12 months
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.
Time Frame: Approximately 6 months
The rates of drug-related adverse events will be summarized, and further evaluated in specific tumor types.
Approximately 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and Tolerability of CDX-585 as assessed by CTCAE v5.0
Time Frame: From first dose through 90 days after last dose
The rates of drug-related adverse events will be summarized and evaluated.
From first dose through 90 days after last dose
Objective Response Rate
Time Frame: Assessed up to approximately 1-3 years.
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
Time Frame: Assessed up to approximately 1-3 years.
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
Time Frame: First occurrence of a documented objective response to disease progression or death (up to approximately 1-3 years)
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
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)
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
Time Frame: The time from start of study drug to death from any cause (up to approximately 1-3 years)
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
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
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
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Celldex Therapeutics

Study record dates

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 Major Dates

Study Start (Actual)

May 11, 2023

Primary Completion (Actual)

May 21, 2025

Study Completion (Actual)

May 21, 2025

Study Registration Dates

First Submitted

March 15, 2023

First Submitted That Met QC Criteria

March 15, 2023

First Posted (Actual)

March 29, 2023

Study Record Updates

Last Update Posted (Actual)

June 15, 2025

Last Update Submitted That Met QC Criteria

June 12, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDX585-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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