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DEC-205/NY-ESO-1 Fusion Protein CDX-1401 · 1 trial · 3 indications
To determine the safety of fixed doses of DEC205mAb-NY-ESO-1 fusion protein with adjuvant poly-ICLC given as a vaccine in combination with INCB024360 300mg, number of Participants with Dose Limiting Toxicities is reported
Percentage of Participants with Progression Free Survival Using irRC Criteria for Phase II Patients are reported. irRC criteria disease progression is defined as at least 25% increase in tumor burden compared with nadir (at any single time point) in two consecutive observations at least 4 weeks apart.
All patients enrolled in this study will be eligible for the analysis of toxicity. The toxicity rate will be estimated using a one-sided, 95%, exact binomial confidence interval (Clopper-Pearson).
| Arm | Type | Description |
|---|---|---|
| Arm I (CDX-1401, poly ICLC) | EXPERIMENTAL | Patients receive DEC-205/NY-ESO-1 fusion protein CDX-1401 and poly ICLC as in Phase I. |
| Arm II (CDX-1401, poly ICLC, IDO1 inhibitor INCB024360) | EXPERIMENTAL | Patients receive DEC-205/NY-ESO-1 fusion protein CDX-1401, poly ICLC, and IDO1 inhibitor INCB024360 as in Phase I. |
| Name | Type | Description |
|---|---|---|
| DEC-205/NY-ESO-1 Fusion Protein CDX-1401 | BIOLOGICAL | Given via intracutaneous injection |
| Epacadostat | DRUG | Given PO |
| Laboratory Biomarker Analysis | OTHER | Correlative studies |
| Pharmacological Study | OTHER | Correlative studies |
| Poly ICLC | DRUG | Given SC |
Inclusion Criteria: * Eligible patients will be women with epithelial ovarian, fallopian tube, or primary peritoneal carcinoma after chemotherapy with no evidence of disease or minimal residual disease for primary or recurrent disease; this may or may not be measurable; these patients would normall...
DEC-205/NY-ESO-1 Fusion Protein CDX-1401 is an investigational monoclonal antibody being studied for the treatment of fallopian tube carcinoma, as well as ovarian and primary peritoneal carcinoma. It is currently in Phase 1 clinical development and is not approved by the FDA.
DEC-205/NY-ESO-1 Fusion Protein CDX-1401 is a fusion protein that combines an antibody targeting DEC-205, a receptor on dendritic cells, with the tumor antigen NY-ESO-1. This design aims to deliver the antigen to dendritic cells to stimulate an immune response against cancer cells expressing NY-ESO-1.
DEC-205/NY-ESO-1 Fusion Protein CDX-1401 is being developed by Incyte Corporation, which is publicly traded under the ticker symbol INCY on the NASDAQ stock exchange.
DEC-205/NY-ESO-1 Fusion Protein CDX-1401 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA for any use.
DEC-205/NY-ESO-1 Fusion Protein CDX-1401 has been studied in one completed clinical trial, NCT02166905. This Phase 1 trial enrolled 40 female patients with ovarian, fallopian tube, or primary peritoneal cancer in remission and was conducted in the United States.
Yes, DEC-205/NY-ESO-1 Fusion Protein CDX-1401 is also known as CDX-1401. The drug is a fusion protein combining an anti-DEC-205 antibody with the NY-ESO-1 tumor antigen, and it is being investigated for its potential role in cancer immunotherapy.