A Phase I/II, Open-Label, Dose Escalation Study of CDX-1401 in Patients with Malignances Known to Express NY-ESO-1

Study Status

Closed to Enrollment

Study Description

NY-ESO-1 is a protein that is often made by some types of tumor cells, but only made by a few types of normal cells. Because it is primarily made by cancer cells, the NY-ESO-1 protein is a promising target against which to stimulate an immune response that may destroy cancer cells. CDX-1401 is a cancer vaccine that is specially designed to create this type of immune response. To enhance the immune response, CDX-1401 will be given with 1 or 2 immune stimulants called Resiquimod and poly-ICLC (Hiltonol).

This clinical trial includes Phase 1 and Phase 2 segments. During the Phase 1 segment, five groups of 6 to 9 patients will be treated with different dose levels of CDX-1401 (the study vaccine) in combination with either one or both of the immune stimulants (Resiquimod and/or poly-ICLC). This phase of the study will test the safety profile of the vaccine treatment, and will assess which dose to test in future studies.

During the Phase 2 segment, 11 patients whose cancer tested positive for the NY-ESO-1 protein in laboratory testing will receive the study treatment to determine if it has an effect on their cancer. All patients enrolled in either part of the study may continue to receive study treatment until their disease has progressed or until it is necessary to stop the treatment for safety or other reasons. In addition, all patients will be followed for 24 months after enrollment in order to collect survival information.

Disease Status and/or Stage

Progressive Disease after therapies with curative potential or approved salvage regimen

Sponsor

Celldex Therapeutics

Key Eligibility

  • Men and women age 18 or older
  • Have cancer that is known to express NY-ESO-1, including but not limited to cancer of the bladder, breast, ovary, non-small lung cancer, myeloma, sarcoma, or melanoma
  • Have cancer that has progressed after any therapies with cuartive potential or approved salvage therapies (if such therapies exist)
  • Have evaluable or measurable tumors
  • Have adequate blood, bone marrow, liver and kidney fuction as determined by laboratory tests
  • Have a sample of tumor tissue available for NY-ESO-1 testing at a central laboratory
  • If of childbearing potential (men and women), agree to practice an effective form of contraception (birth control) during study treatment
  • Additional eligibility to be discussed when you contact the study team

Principal Investigator

Ellen Chuang, MD

Contact

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Contact Us

For general inquiries, or if you need assistance finding a study, please contact:

Robert Hagerty
Subject Recruitment Manager
Tel: (646) 962-9340
[email protected]

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