Last updated on January 2020

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

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Pancreatic Adenocarcinoma | Colorectal Cancer | Diffuse Large B-Cell Lymphoma | Gastric Cancer | Non-Hodgkin's Lymphoma | Renal Cell Cancer | Mantle cell lymphoma | HEPATIC NEOPLASM | melanoma | head and neck cancer | Primary Peritoneal Cancer | Renal Cell Carcinoma | Colon Cancer Screening | Ovarian Cancer | Esophageal Cancer | Lymphoma | Breast Cancer | Fallopian Tube Cancer | Solid Tumor | Other Solid Tumors | Metastatic Melanoma | Recurrent Ovarian Cancer | Bladder Urothelial Carcinoma | Malignant Melanoma | Cholangiocarcinoma | Colon cancer; rectal cancer | Stomach Cancer | Non-Small Cell Lung Cancer | Indolent B-cell Lymphomas | skin cancer | Liver Cancer
  • Age: Between 18 - 100 Years
  • Gender: Male or Female

Inclusion Criteria:

  1. Diagnosed with one of the following:
    • 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.
    • Advanced diffuse large B-cell lymphoma (DLBCL), mantle cell lymphoma, or indolent B-cell lymphoma
  2. Criteria A and B:
  3. For patients with solid tumors:
    • Must have received all standard of care therapies (approved or unapproved) as deemed appropriate by the treating physician
    • Patients are not required to have all approved therapies in a particular class of drugs (e.g. all approved tyrosine kinase inhibitors for patients with renal cell carcinoma or all approved checkpoint blockade antibodies for patients with melanoma)
    • Patients who refuse standard therapy are excluded from the study
  4. For patients with lymphoma: Must have received 1 prior systemic therapy
  5. Measurable disease.
  6. Life expectancy 12 weeks.
  7. 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.
  8. Willingness to undergo a pre-treatment and on-treatment biopsy, if required.

Exclusion Criteria:

  1. History of severe hypersensitivity reactions to other monoclonal antibodies.
  2. Previous treatment with any anti-CD40 antibody or with FLT3L.
  3. Received any antibody targeting T-cell check point or co-stimulation pathways within 4 weeks, received any other monoclonal antibody within 4 weeks, and all other immunotherapy (tumor vaccine, cytokine, or growth factor) within 2 weeks prior to study treatment.
  4. Prior T-cell or other cell-based therapies within 12 weeks (or 2 weeks if patient experienced disease progression on the prior treatment)
  5. For lymphoma patients:
    • Prior allogenic stem cell transplantation
    • Patients who have received autologous stem cell transplant 12 weeks prior to the first dose of study drug.
  6. Chemotherapy within 21 days (6 weeks for nitrosoureas) or at least 5 half-lives (whichever is longer) prior to study treatment.
  7. Received any kinase inhibitors within 2 weeks prior to study treatment.
  8. Systemic radiation therapy within 4 weeks, prior focal radiotherapy within 2 weeks, or radiopharmaceuticals (strontium, samarium) within 8 weeks prior to study treatment.
  9. Major surgery within 4 weeks prior to study treatment.
  10. Use of immunosuppressive medications within 4 weeks or systemic corticosteroids within 2 weeks prior to study treatment.
  11. 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.
  12. Active, untreated central nervous system metastases.
  13. Active autoimmune disease or documented history of autoimmune disease.
  14. Active infection requiring systemic therapy, known infection of HIV, Hepatitis B, or Hepatitis C.
  15. Significant cardiovascular disease including Congestive Heart Failure or poorly controlled hypertension.

There are additional criteria your study doctor will review with you to confirm your eligibility for the study.

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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