Non-small Cell Lung CancerPhase 1NCT05788484
A Study of CDX-585 in Patients With Advanced Malignancies
A Phase 1 study testing CDX-585 in people with Non-small Cell Lung Cancer and Gastric Cancer, run by Celldex Therapeutics at 4 sites in United States.
Trial summary
This is an open-label, non-randomized, multicenter, dose-escalation and expansion study in patients with selected solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer, Gastric Cancer, Head and Neck Cancer
- What is being tested?
- CDX-585
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 4 sitesUnited States
- Study dates
- 11 May 2023to 21 May 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
AdventHealth Celebration
Celebration, Florida, 34747
Perlmutter Cancer Center at NYU Langone Health
New York, New York, 10016
Providence Cancer Institute
Portland, Oregon, 97213
George Washington University Cancer Center
Washington D.C., District of Columbia, 20037
About this study
Official title: 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.
Read the 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.
- Conditions
- Non-small Cell Lung Cancer, Gastric Cancer, Head and Neck Cancer, Ovarian Cancer, Primary Peritoneal Carcinoma, Fallopian Tube Cancer
- Being tested
- CDX-585
- Keywords
- LILRB2, CD85d, ILT-4, PD1, Bi-Specific, Immunotherapy, Solid tumor Malignancies, Dose escalation, Immunological
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Stomach Neoplasms, Head and Neck Neoplasms, Ovarian Neoplasms, Fallopian Tube Neoplasms, Colorectal Neoplasms, Esophageal Neoplasms, Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CDX-585Drug
CDX-585 is administered by infusion every 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| CDX-585 | Experimental | 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. Receives: Drug: CDX-585 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Approximately 6 months
Secondary outcomes (8)
Safety and Tolerability of CDX-585 as assessed by CTCAE v5.0
The rates of drug-related adverse events will be summarized and evaluated.
Measured: From first dose through 90 days after last dose
Objective Response Rate
The percentage of patients who achieve a confirmed immune complete response (iCR) or immune partial response (iPR)
Measured: Assessed up to approximately 1-3 years.
Clinical Benefit Rate
The percentage of patients who achieve best response of confirmed iCR or iPR, or immune stable disease (iSD) for at least four months
Measured: Assessed up to approximately 1-3 years.
Duration of Response
The interval from which measurement criteria are first met for iCR or iPR until the first date that progressive disease is objectively documented
Measured: First occurrence of a documented objective response to disease progression or death (up to approximately 1-3 years)
Progression-free Survival
The time from start of study drug to time of progression or death, whichever occurs first
Measured: 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
The time from start of study drug to death
Measured: The time from start of study drug to death from any cause (up to approximately 1-3 years)
Pharmacokinetic Evaluation
CDX-585 serum concentrations will be measured at specified visits
Measured: 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
Samples will be obtained for assessment of human anti-CDX-585
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2023
- Study start11 May 2023
- Primary completion21 May 2025
- Study completion21 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celldex Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05788484
- Sponsor's protocol ID
- CDX585-01
- Status last verified
- Apr 2025
- First submitted
- 15 Mar 2023
- Last updated
- 15 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Dose-escalation and Expansion Study of the PD-1 x ILT4 Bispecific Antibody CDX-585 in Patients With Advanced Malignancies
- ClinicalTrials.gov ID
- NCT05788484
- Acronym / sponsor ID
- CDX585-01
- Conditions
- Non-small Cell Lung Cancer, Gastric Cancer, Head and Neck Cancer, Ovarian Cancer, Primary Peritoneal Carcinoma, Fallopian Tube Cancer
- Keywords
- LILRB2, CD85d, ILT-4, PD1, Bi-Specific, Immunotherapy, Solid tumor Malignancies, Dose escalation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Celldex TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 11 May 2023 (actual)
- Primary completion
- 21 May 2025 (actual)
- Study completion
- 21 May 2025 (actual)
- First posted
- 29 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-label, non-randomized, multicenter, dose-escalation and expansion study in patients with selected solid tumors.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CDX-585 | Experimental | Drug: CDX-585Dose-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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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 (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CDX-585CDX-585 is administered by infusion every 2 weeks | Drug | CDX-585 |
Primary outcome
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.
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.
8 secondary outcomes
Safety and Tolerability of CDX-585 as assessed by CTCAE v5.0
Time frame: From first dose through 90 days after last dose
Objective Response Rate
Time frame: Assessed up to approximately 1-3 years.
Clinical Benefit Rate
Time frame: 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)
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)
Overall Survival
Time frame: 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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CDX-585 in people with Non-small Cell Lung Cancer and Gastric Cancer, run by Celldex Therapeutics at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2025.