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
1 other identifier
interventional
20
1 country
4
Brief Summary
This is an open-label, non-randomized, multicenter, dose-escalation and expansion study in patients with selected solid tumors.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 nonsmall-cell-lung-cancer
Started May 2023
Shorter than P25 for phase_1 nonsmall-cell-lung-cancer
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 15, 2023
CompletedFirst Posted
Study publicly available on registry
March 29, 2023
CompletedStudy Start
First participant enrolled
May 11, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 21, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
May 21, 2025
CompletedJune 15, 2025
April 1, 2025
2 years
March 15, 2023
June 12, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (8)
Safety and Tolerability of CDX-585 as assessed by CTCAE v5.0
From first dose through 90 days after last dose
Objective Response Rate
Assessed up to approximately 1-3 years.
Clinical Benefit Rate
Assessed up to approximately 1-3 years.
Duration of Response
First occurrence of a documented objective response to disease progression or death (up to approximately 1-3 years)
Progression-free Survival
Cycle 1, day 1 to the first occurrence of disease progression or death due to any cause (up to approximately 1-3 years)
- +3 more secondary outcomes
Study Arms (1)
CDX-585
EXPERIMENTALDose-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.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
George Washington University Cancer Center
Washington D.C., District of Columbia, 20037, United States
AdventHealth Celebration
Celebration, Florida, 34747, United States
Perlmutter Cancer Center at NYU Langone Health
New York, New York, 10016, United States
Providence Cancer Institute
Portland, Oregon, 97213, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 15, 2023
First Posted
March 29, 2023
Study Start
May 11, 2023
Primary Completion
May 21, 2025
Study Completion
May 21, 2025
Last Updated
June 15, 2025
Record last verified: 2025-04