CompletedPhase 1NCT05788484

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.

Checked against the public recordLast updated Jun 15, 2025 · Source: ClinicalTrials.gov

StatusCompleted
PhasePhase 1
U.S. locations4
SponsorCelldex Therapeutics
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1
Sponsor
Celldex Therapeutics
Interventions being studied
Drug: CDX-585
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

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.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • George Washington University Cancer CenterWashington D.C., District of Columbia
  • AdventHealth CelebrationCelebration, Florida
  • Perlmutter Cancer Center at NYU Langone HealthNew York, New York
  • Providence Cancer InstitutePortland, Oregon

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jun 15, 2025. Always confirm current availability with the study team.

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