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Completed

NCT Number: NCT05788484

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.

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Key information

Conditions

Non-small Cell Lung Cancer Adenocarcinoma Adnexal Diseases Bladder Urothelial Carcinoma Bronchial Neoplasms Carcinoma Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Carcinoma, Renal Cell Cholangiocarcinoma Colonic Diseases Colorectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Esophageal Cancer Esophageal Diseases Esophageal Neoplasms Fallopian Tube Cancer Fallopian Tube Diseases Fallopian Tube Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastric Cancer Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Head and Neck Cancer Head and Neck Neoplasms Hepatic Cancer Intestinal Diseases Intestinal Neoplasms Kidney Diseases Kidney Neoplasms Liver Diseases Liver Neoplasms Lung Diseases Lung Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Other Solid Tumors Ovarian Cancer Ovarian Diseases Ovarian Neoplasms Pancreatic Cancer Pancreatic Diseases Pancreatic Neoplasms Primary Peritoneal Carcinoma Rectal Diseases Renal Cell Carcinoma Respiratory Tract Diseases Respiratory Tract Neoplasms Stomach Diseases Stomach Neoplasms Thoracic Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

George Washington University Cancer Center, Washington D.C., District of Columbia, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • Recurrent, locally advanced, or metastatic solid tumor cancer excluding primary central nervous system tumors (e.g., glioblastoma).
  • Receipt of standard therapy for the tumor type in the recurrent, locally advanced, or metastatic setting.
  • Measurable (target) disease by iRECIST.
  • 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.
  • Willingness to undergo a pre-treatment and on-treatment biopsy, if required.

Key Exclusion Criteria:

  • History of severe hypersensitivity reactions to other monoclonal antibodies.
  • Previous treatment with any anti-ILT4 antibody.
  • Patients who have received more than 1 anti-PD-1 or anti-PD-L1 targeted therapy, including in the adjuvant setting.
  • 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.
  • 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.
  • Thrombotic events within the last six months prior to study treatment
  • Active, untreated central nervous system metastases.
  • Active autoimmune disease or documented history of autoimmune disease.
  • History of (non-infectious) pneumonitis or has current pneumonitis.

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

Treatment and study plan

CDX-585

Drug

CDX-585 is administered by infusion every 2 weeks

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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)

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

Sponsors and collaborators

Lead sponsor

Celldex Therapeutics

Industry

Registry information

Official study title

A Phase 1 Dose-escalation and Expansion Study of the PD-1 x ILT4 Bispecific Antibody CDX-585 in Patients With Advanced Malignancies

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Mar 29, 2023
Registry last updated
Jun 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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