drugset / Trial / NCT02015416

A Phase 1 Trial of NY-ESO-1 With GLA-SE in Patients With Unresectable or Metastatic Cancer

NCT02015416

Phase 1 Completed 13 enrolled Immune Design
SequentialOpen-labelTreatment

Summary

This is a Phase I, multi-center, multiple ascending dose study to evaluate the clinical safety and immune response of IDC-G305 when injected intramuscularly in patients with unresectable or metastatic cancer. IDC-G305 is an immunotherapy consisting of recombinant NY-ESO-1 antigen and the adjuvant, GLA-SE. The goal is for IDC-G305 to stimulate the body's immune system to fight the spread and growth of cancer for patients whose tumors include the NY-ESO-1 protein. Patients with melanoma, ovarian, renal cell or non-small cell lung cancer may be considered for the trial.

Timeline

Start
2013-11
Primary completion
2016-12
Completion
2017-03

Drugs

EvaluationDrugModalityDoseRoute
Subject NY-ESO-1 recombinant protein Protein / enzyme biologic Intramuscular
Background GLA-SE Other / unclassified Intramuscular