CDX-585 for Cancer

Recruiting at 3 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

130 Participants Needed

Trial Summary

What is the purpose of this trial?

This is an open-label, non-randomized, multicenter, dose-escalation and expansion study in patients with selected solid tumors.

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.

Eligibility Criteria

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

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

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

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

Treatment Details

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.

Participant Groups

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