CDX-1401: Clinical Program

A vaccine for NY-ESO-1 expressing malignancies

Our second APC Targeting Technology™ product candidate, CDX-1401, is in Phase 1/2 development for the treatment of cancers known to express NY-ESO-1, including cancers of the bladder, breast, ovary, non-small cell lung cancer, myeloma, sarcoma and melanoma. CDX-1401 is a fusion protein consisting of a fully human monoclonal antibody with specificity for the dendritic cell receptor, DEC-205 linked to the NY-ESO-1 tumor antigen. This product is intended to selectively deliver the NY-ESO-1 antigen to Antigen-Presenting Cells (APCs) for generating robust immune responses against cancer cells expressing NY-ESO-1. NY-ESO-1 is a protein that is expressed in a wide variety of cancer cells but not at significant levels in most normal tissues. NY-ESO-1 has been extensively characterized in pre-clinical and clinical studies and has been found to be highly immunogenic, and represents an important target for developing therapeutics against multiple cancers.

About the Clinical Trial

This Phase 1/2 trial will examine the safety, immune response, pharmacokinetics, and anti-tumor activity of CDX-1401 when given in combination with immune stimulating agents (resiquimod and/or poly-ICLC) to patients with malignancies known to express NY-ESO-1.

Approximately 48 patients will be enrolled. During the first part of the study, three groups of 6 to 9 patients will be treated with different dose levels of CDX-1401 in combination with resiquimod. A fourth cohort will receive CDX-1401 in combination with poly-ICLC, while a fifth cohort will receive CDX-1401 in combination with both poly-ICLC and resiquimod. In the second part of the study, approximately 11 patients whose cancer tested positive for the NY-ESO-1 protein in laboratory testing will receive CDX-1401 at the dose and combination that appears most promising (based on safety, immune response and early activity data from the previously enrolled patients). Patients whose tumors do not progress and who tolerate treatment may receive additional “cycles” of treatment on a 12 week-schedule. Study follow-up will continue for 24 months after enrollment.

Patient Eligibility

Among other criteria, patients must meet all of the following conditions to be eligible to be in the study:

• 18 years of age or older
• Have a cancer type that is known to express NY-ESO-1, including but not limited to cancer of the bladder, breast, ovary, non-small cell lung cancer, myeloma, sarcoma or melanoma
• Have cancer that has progressed after any therapies with curative potential or approved salvage therapies (if such therapies exist)
• Have evaluable or measurable tumors
• Have adequate blood, bone marrow, liver and kidney function as determined by laboratory tests
• Have a sample of tumor tissue available for NY-ESO-1 testing at a central laboratory; Positive NY-ESO-1 expression will be required for patients enrolled in the second stage of the study
• If of childbearing potential (male or female), agree to practice an effective form of contraception during study treatment

Among other criteria, patients who meet any of the following conditions are NOT eligible to be in the study:

• Are receiving treatment with immunosuppressive or immunomodulatory agents, including any systemic steroid (inhaled or topically applied steroids are permitted)
• Have a known infection with HIV, HBV or HCV, or any other active infection requiring systemic antibiotic treatment; patients with prior exposure to hepatitis, but no evidence of active or chronic infection, may be eligible
• Have active central nervous system tumors
• Have autoimmune disease requiring therapy, aside from minor localized inflammatory disease (less than 20% of the skin surface) controlled with topical therapy
• Any underlying medical condition that, in the Principal Investigator's opinion, will make the administration of study drug hazardous or otherwise interfere with the study

Please click here for more information about this trial, including a list of clinical trial sites and contact information for prospective patients.