CompletedPhase 1NCT04440943
Official study title

A Study of the PD-L1xCD27 Bispecific Antibody CDX-527 in Patients With Advanced Malignancies

Study summary

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

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedCDX-527

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · PD-L1

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jun 18, 2023 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1

Interventional

Where is it offered?5 U.S. locations

Locations may change over time.

Who runs it?Celldex Therapeutics

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1
Sponsor
Celldex Therapeutics
Interventions being studied
Drug: CDX-527
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

Key 1. Recurrent, locally advanced or metastatic solid tumor cancer excluding the following: MSI-low colorectal cancer, glioblastoma multiforme, prostate cancer, pancreatic cancer, mucosal and ocular melanoma. 2. Receipt of all standard therapies for the tumor type 3. Measurable (target) disease by iRECIST 4. 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 5. Willingness to undergo a pre-treatment and on-treatment biopsy, if required Key

Reasons someone may not be able to joinExclusion criteria

1. History of severe hypersensitivity reactions to other monoclonal antibodies. 2. Previous treatment with any anti-CD27 antibody. 3. Inadequate washout period from prior therapy as defined in the Protocol. 4. Patients who have received more than 0 or 1 prior PD-1/PD-L1 inhibitor depending on their tumor type 5. Major surgery within 4 weeks prior to study treatment. 6. Use of immunosuppressive medications within 4 weeks or systemic corticosteroids within 2 weeks prior to study treatment. 7. 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 3 years to be allowed to enroll. 8. Thrombotic events within the last 6 months prior to study treatment 9. Active, untreated central nervous system metastases. 10. Active autoimmune disease or documented history of autoimmune disease. 11. History of (non-infectious) pneumonitis or has current pneumonitis. 12. Active diverticulitis 13. Known infection of HIV, Hepatitis B, or Hepatitis C. There are additional criteria your study doctor will review with you to confirm your eligibility for the study.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Northside HospitalAtlanta, Georgia
  • University of ChicagoChicago, Illinois
  • Oncology Hematology West, PC dba Nebraska Cancer SpecialistsOmaha, Nebraska
  • Duke Cancer CenterDurham, North Carolina
  • Providence Portland Medical CenterPortland, Oregon

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jun 18, 2023. Always confirm current availability with the study team.

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