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.
| Currently Enrolling | |
| Phase 1/2: Advanced cancers of the bladder, breast, ovary, non-small cell lung cancer, myeloma, sarcoma or melanoma | |
| Design: | Phase 1/2, open-label, dose-escalation study of CDX-1401 plus resiquimod |
| Status: | Currently enrolling at multiple centers in the US |
This Phase 1/2 trial will examine the safety, immune response, pharmacokinetics, and anti-tumor activity of CDX-1401 when given in combination with an immune stimulating agent (resiquimod) to patients with malignancies known to express NY-ESO-1.
CDX-1401 will be administered as an injection into the skin every 2 weeks for 4 doses, while resiquimod gel will be applied to the skin on the day of and the day after the CDX-1401 administrations. 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.
Approximately 38 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 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 that appears most promising (based on safety, immune response and early activity data from the previously enrolled patients).
Among other criteria, patients must meet all of the following conditions to be eligible to be in the study:
Among other criteria, patients who meet any of the following conditions are NOT eligible to be in the study:
Please click here for more information about this trial, including a list of clinical trial sites and contact information for prospective patients.