CompletedPhase 1NCT03329950
Official study title

A Study of CDX-1140 (CD40) as Monotherapy or in Combination in Patients With Advanced Malignancies

Study summary

This is a study to determine the maximum tolerated dose (MTD) for CDX-1140 (CD40 antibody), either alone or in combination with CDX-301 (FLT3L), pembrolizumab, or chemotherapy and to further evaluate its tolerability and efficacy in expansion cohorts once the MTD is determined.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedCDX-1140 and CDX-301

Plus 2 other study approaches.

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

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Mar 28, 2024 · 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?11 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-1140; Drug: CDX-301; Drug: pembrolizumab; Drug: Chemotherapy
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 melanoma (including mucosal and/or ocular), bladder/urothelial, non-small cell lung cancer, pancreatic adenocarcinoma, breast, colorectal, gastric, esophageal, renal cell, hepatic, ovarian fallopian or primary peritoneal carcinoma, head and neck, and cholangiocarcinoma. Additional tumor types (except primary CNS tumors) may be enrolled after discussion with, and approval from, the medical monitor. 2. Must have received all standard of care therapies (approved or unapproved) as deemed appropriate by the treating physician. Patients who refuse standard therapy are excluded from the study. 3. 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 4. Willingness to undergo a pre-treatment and on-treatment biopsy, if required. Additional Inclusion Criteria for Part 1: 1. Advanced diffuse large B-cell lymphoma (DLBCL), mantle cell lymphoma, or indolent B-cell lymphoma are also eligible. 2. Lymphoma patients must have received ≥ 1 prior systemic therapy Additional Inclusion Criteria for Part 3: 1. Patients must have documented progression while receiving anti-PD-1 or anti-PD-L1 based regimens for FDA approved indications 2. Patients cannot have received more than one anti-PD-1 or anti-PD-L1 based regimen Additional Inclusion Criteria for Part 4: 1\. Patients must have metastatic pancreatic adenocarcinoma, and have not received previous treatment in a metastatic setting 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-CD40 antibody or with FLT3L. 3. Inadequate washout period from prior therapy as defined in the Protocol. 4. Major surgery within 4 weeks prior to study treatment. 5. Use of immunosuppressive medications within 4 weeks or systemic corticosteroids within 2 weeks prior to study treatment. 6. 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. 7. Active, untreated central nervous system metastases. 8. Active autoimmune disease or documented history of autoimmune disease. 9. History of (non-infectious) pneumonitis or has current pneumonitis. 10. Active infection requiring systemic therapy, known infection of HIV, Hepatitis B, or Hepatitis C. Additional

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

  • HonorHealth Research InsitituteScottsdale, Arizona
  • Northside Hospital, Inc.Atlanta, Georgia
  • Georgia Cancer Center at Augusta UniversityAugusta, Georgia
  • Oncology Hematology West, PC dba Nebraska Cancer SpecialistsOmaha, Nebraska
  • Icahn School of Medicine at Mount SinaiNew York, New York
  • Memorial Sloan Kettering Cancer CenterNew York, New York
  • Gabrail Cancer Center Research LLCCanton, Ohio
  • Providence Portland Medical CenterPortland, Oregon
  • Abramson Cancer Center at the University of PennsylvaniaPhiladelphia, Pennsylvania
  • Rhode Island Hospital (RIH) The Miriam Hospital (TMH)Providence, Rhode Island
  • Houston MethodistHouston, Texas

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Mar 28, 2024. Always confirm current availability with the study team.

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