drugset / Trial / NCT02015416
A Phase 1 Trial of NY-ESO-1 With GLA-SE in Patients With Unresectable or Metastatic Cancer
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | NY-ESO-1 recombinant protein | Protein / enzyme biologic | — | Intramuscular |
| Background | GLA-SE | Other / unclassified | — | Intramuscular |