CDX-585 for Cancer

No longer recruiting at 4 trial locations

Overseen By Celldex Therapeutics

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Celldex Therapeutics

Must not be taking: Anti-ILT4, Anti-PD-1

Disqualifiers: Autoimmune disease, Pneumonitis, Thrombotic events, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to find the most effective dose of CDX-585, an experimental treatment, for individuals with certain advanced solid tumors. Participants will receive the treatment in cycles, helping to determine its effectiveness and potential side effects. The study seeks individuals with solid tumors that have returned or spread after standard treatments, excluding those with primary brain tumors like glioblastoma. Those who have previously tried certain immune therapies and still require treatment for a solid tumor may qualify for this trial. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive it.

Do I need to stop my current medications to join the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the study doctor to understand any specific requirements.

Is there any evidence suggesting that CDX-585 is likely to be safe for humans?

Research has shown that CDX-585 has promising safety results from early testing. In lab studies on animals, doses of CDX-585 up to 60 mg/kg were well tolerated, with no serious side effects observed. While this provides a good starting point, human trials are necessary to fully understand the treatment's safety for people.

As a Phase 1 trial, this marks the first time CDX-585 is tested in humans. The main goal is to determine the safe dosage and potential side effects. Although human data is limited, the animal studies offer helpful insights. Phase 1 trials often involve close monitoring to ensure participants' safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for cancer, which often include chemotherapy and radiation that target rapidly dividing cells broadly, CDX-585 is unique because it specifically targets cancer cells. Researchers are excited about CDX-585 because it utilizes a novel mechanism of action designed to enhance the immune system's ability to attack tumor cells more effectively. This targeted approach not only promises to be more effective but also aims to reduce the side effects typically associated with traditional cancer therapies.

What evidence suggests that CDX-585 might be an effective treatment for cancer?

Research has shown that CDX-585, the investigational treatment in this trial, targets two specific proteins: PD-1 and ILT4. These proteins help cancer cells evade the immune system. By blocking them, CDX-585 enables the body’s natural defenses to attack cancer cells more effectively. In studies with mice, CDX-585 demonstrated stronger effects against tumors than treatments used alone. It also aids the immune system in releasing substances that fight cancer. These early results suggest CDX-585 could be promising for treating solid tumors. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for adults with various advanced cancers who've had standard treatment. They must be willing to use birth control and undergo biopsies. It's not for those with brain tumors, recent thrombosis, active pneumonitis, untreated brain metastases, autoimmune diseases, or a history of severe reactions to monoclonal antibodies.

Inclusion Criteria

I have received standard treatment for my cancer in its advanced stages.

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

I am willing to have biopsies before and during treatment if needed.

Exclusion Criteria

I haven't had anti-PD-L1 therapy in the last 12 weeks or anti-PD-1 therapy in the last 4 weeks.

I've been cancer-free for a year, except for minor skin cancers or in situ cancers.

History of severe hypersensitivity reactions to other monoclonal antibodies

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose-escalation

Eligible patients will receive treatment in 2-week cycles to determine the maximum tolerated dose of CDX-585

Approximately 12 months

Bi-weekly visits

Expansion

Patients will receive CDX-585 at the dose level chosen during the escalation phase to further evaluate safety in selected tumor types

Approximately 6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 3 years

What Are the Treatments Tested in This Trial?

Interventions

• CDX-585

Trial Overview CDX-585 is being tested in this study where all participants receive the drug openly without randomization. The trial aims to find the right dose and see how well it works across different types of advanced solid tumors.

How Is the Trial Designed?

Group I: CDX-585 Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Celldex Therapeutics

Lead Sponsor

Trials

66

Recruited

5,900+

Anthony S. Marucci

Celldex Therapeutics

Chief Executive Officer since 2008

MBA from Columbia University, MHL from Brown University

Diane C. Young

Celldex Therapeutics

Chief Medical Officer since 2019

MD from Harvard Medical School, AB in Biochemical Sciences from Harvard University

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05788484

A Study of CDX-585 in Patients With Advanced Malignancies 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.

2. aacrjournals.org aacrjournals.org/cancerres/article/83/7_Supplement/2963/723809/Abstract-2963-CDX-585-a-novel-bispecific-antibody

CDX-585, a novel bispecific antibody targeting PD-1 and ILT4 Similarly, CDX-585 demonstrated superior anti-tumor activity over the combination of the parental mAbs in a humanized mouse model of melanoma.

3. mdpi.com mdpi.com/2673-5601/3/3/18

CDX-585, a Bispecific Antibody with Dual Targeting of ILT4 ... CDX-585 is a potent antagonist of both PD-1 and ILT4. CDX-585 promotes M1 macrophage polarization and enhances pro-inflammatory cytokine secretion.

4. ir.celldex.com ir.celldex.com/news-releases/news-release-details/celldex-announces-first-patient-dosed-phase-1-study-cdx-585

Celldex Announces First Patient Dosed in Phase 1 Study ... CDX-585 is a dual targeting PD-1/ILT4 bispecific antibody from Celldex's bispecific antibody platform. Expression of ILT4 in several tumor types ...

5. fiercebiotech.com fiercebiotech.com/biotech/celldex-drops-phase-1-solid-tumor-bispecific-focus-inflammation

Celldex drops phase 1 solid tumor bispecific to focus on ... The company had completed a phase 1 trial of CDX-585, a bispecific antibody targeting PD-1 and ILT4 in patients with advanced or metastatic ...

6. ctv.veeva.com ctv.veeva.com/study/a-study-of-cdx-585-in-patients-with-advanced-malignancies

A Study of CDX-585 in Patients With Advanced Malignancies This study will determine the maximum tolerated dose of CDX-585 while also evaluating the safety, tolerability, and efficacy of CDX-585 in ...