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CDX-1401 in combination with Resiquimod and/or Poly-ICLC · 1 trial · 1 indication
| Name | Type | Description |
|---|---|---|
| CDX-1401 in combination with Resiquimod and/or Poly-ICLC | BIOLOGICAL | CDX-1401 is administered as an injection into the skin every 2 weeks for 4 doses. It is given in combination with Resiquimod and/or poly-ICLC. Resiquimod is administered as a topical gel applied to the skin or given as an injection under the skin, and poly-ICLC is given as an injection under the skin. Depending on the treatment group assignment, either one or both of the immune stimulants will be given on the day of and the day after CDX-1401 administrations. This treatment may be repeated every 12 weeks. |
| CDX-1401 | BIOLOGICAL | - |
| Resiquimod | BIOLOGICAL | - |
| poly-ICLC | BIOLOGICAL | - |
Inclusion Criteria: Among other criteria, patients must meet all of the following conditions to be eligible to be in the study: 1. 18 years of age or older. 2. 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 ...
CDX-1401 is an investigational immunotherapy studied in patients with advanced malignancies known to express NY-ESO-1. It was evaluated in combination with immune adjuvants resiquimod and/or Poly-ICLC in a single Phase 1 trial of 70 patients. It is not an approved treatment.
CDX-1401 is being developed by Celldex Therapeutics, Inc., which trades on the Nasdaq under the ticker CLDX. The company sponsored the Phase 1 study of the agent in patients with NY-ESO-1-expressing malignancies.
CDX-1401 is in Phase 1 development. The only listed trial, NCT00948961, was a Phase 1 study that has been completed. No active trials are currently listed, and the agent remains investigational rather than approved.
CDX-1401 was studied in one clinical trial, NCT00948961, titled A Study of CDX-1401 in Patients With Malignancies Known to Express NY-ESO-1. This completed Phase 1 trial enrolled 70 patients in the United States and evaluated CDX-1401 with resiquimod and/or Poly-ICLC.
The Phase 1 trial NCT00948961 was an uncontrolled, non-randomized, open-label study. It enrolled 70 adults aged 18 years and older with advanced malignancies known to express NY-ESO-1, and it has been completed.