CompletedPhase 1

A Study of CDX-585 in Patients With Advanced Malignancies

United States20 participantsStarted 2023-05-11

Plain-language summary

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

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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.

What they're measuring

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

Timeframe: Approximately 12 months

Tumor-specific expansion cohorts: To further evaluate the safety of CDX-585 by tumor type.

Timeframe: Approximately 6 months

Trial details

NCT IDNCT05788484

SponsorCelldex Therapeutics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-05-21

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