NCT05788484CompletedPhase 1
A Study of CDX-585 in Patients With Advanced Malignancies
A Phase 1 Dose-escalation and Expansion Study of the PD-1 x ILT4 Bispecific Antibody CDX-585 in Patients With Advanced Malignancies
Source: ClinicalTrials.gov · Last updated 15 Jun 2025
Brief summary (registry, in English)
This is an open-label, non-randomized, multicenter, dose-escalation and expansion study in patients with selected solid tumors.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 20 (actual)
- First submitted
- 15 Mar 2023
- Start date
- 11 May 2023
- Primary completion date
- 21 May 2025
- Lead sponsor
- Celldex Therapeutics
- Diseases
- Head and neck cancer, Kidney cancer, Bladder cancer, Lung cancer, Pancreatic cancer, Colorectal cancer, Liver and biliary tract cancer, Gastric and esophageal cancer, Ovarian cancer
- NCT number
- NCT05788484
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 20
- From 11 May 2023 to the primary completion date, 21 May 2025
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- Thrombotic events within the last six months prior to study treatment
Other illness
- History of severe hypersensitivity reactions to other monoclonal antibodies.
- 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.
- 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.
Other
- Active, untreated central nervous system metastases.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| AdventHealth Celebration Coordinator of this site? Confirm its status | Celebration | United States | Unknown status |
| Perlmutter Cancer Center at NYU Langone Health Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Providence Cancer Institute Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
| George Washington University Cancer Center Coordinator of this site? Confirm its status | Washington D.C. | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.