NCT02015416

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

A Phase 1 Open Label, Multicenter, Multiple Ascending Dose Trial Evaluating the Safety, Tolerability and Immunogenicity of Intramuscular Recombinant NY-ESO-1 Protein With GLA-SE Adjuvant in Patients With Unresectable or Metastatic Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Immune Design, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a Phase 1, open label, multicenter, multiple ascending dose trial of IDC-G305 administered by intramuscular injection in a 3+3 sequential dose escalation design. IDC-G305 is an immunotherapy consisting of recombinant NY-ESO-1 antigen and the adjuvant, GLA-SE. Patients with unresectable, relapsed or metastatic cancer but with low disease burden and indolent disease course may be considered for the trial. Tumors must express the NY-ESO-1 gene signature and tumor types that will be studied are: melanoma, ovarian, sarcoma,non-small cell lung and breast cancer. Each of three dose level cohorts will be treated contingent upon absence of dose limiting toxicity (DLT) and acceptable safety data for the preceding cohort. Initially, three patients will be scheduled to receive IDC-G305 in each dose level cohort. Dose escalation will be contingent upon the assessment of safety data obtained during the initial injections. Patients will be evaluated at baseline and at regular intervals for safety and immune response. Both cellular and humoral immunogenicity will be explored.

Conditions

• Melanoma
• Ovarian Cancer
• Sarcoma
• Non-small Cell Lung Cancer
• Breast Cancer

Interventions

Type	Name	Description
BIOLOGICAL	IDC-G305	NY-ESO-1 recombinant protein together with GLA-SE

Timeline

• Start date: 2013-11-01
• Primary completion: 2016-12-01
• Completion: 2017-03-01
• First posted: 2013-12-19
• Last updated: 2017-08-17

Locations

4 sites across 1 country: United States