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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02015416
• Other study ID #: IDC-G305-2013-001
• Status: Completed
• Phase: Phase 1
• First received: December 13, 2013
• Last updated: August 15, 2017
• Start date: November 2013
• Est. completion date: March 2017

Study information

• Verified date: August 2017
• Source: Immune Design
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: March 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Confirmed diagnosis of melanoma, ovarian cancer, sarcoma, breast cancer or non-small cell lung cancer (NSCLC)

• Unresectable, relapsed and/or metastatic cancer with minimal or low disease burden. Disease may or may not be measurable and should not be rapidly progressive. Inadequate response, relapse and/or unacceptable toxicity with one or more prior systemic, surgical, or radiation cancer therapies, except patients with NSCLC and breast cancer who must have experienced an inadequate response and/or unacceptable toxicity with two or more prior systemic, surgical, or radiation cancer therapies.

• Cancer expresses NY-ESO-1

• = 18 years of age

• Life expectancy of = 6 months

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

• ECG without evidence of clinically significant arrhythmia or ischemia

• Negative pregnancy test for females of childbearing potential

Exclusion Criteria:

• Pregnant or nursing

• Vaccine or other therapy directed against NY-ESO-1 at any time in the past and any investigational therapy within three weeks prior to IDC-G305 dosing

• Significant immunosuppression

• Cancer chemotherapy, G-CSF or GM-CSF within three weeks prior to the first study treatment

• Significant autoimmune disease

• Myocardial infarction within six months of treatment, active cardiac ischemia or Grade III or IV heart failure

• Inadequate hematology or chemistry profiles

• History of other cancer within three years

• Active, concurrent or recent infection, including tuberculosis, hepatitis B, hepatitis C or HIV

• Uveal melanoma

• Brain metastases considered unstable

Related Conditions & MeSH terms

• Breast Cancer
• Carcinoma, Non-Small-Cell Lung
• Melanoma
• Neoplasm Metastasis
• Non-small Cell Lung Cancer
• Ovarian Cancer
• Ovarian Neoplasms
• Sarcoma

Intervention

Biological:
• IDC-G305
NY-ESO-1 recombinant protein together with GLA-SE

Locations

Country	Name	City	State
United States	Roswell Park Cancer Institute	Buffalo	New York
United States	Karmanos Cancer Institute	Detroit	Michigan
United States	Scottsdale Healthcare	Scottsdale	Arizona
United States	H. Lee Moffitt Cancer Center	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Immune Design

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability	To evaluate the safety and tolerability of multiple ascending doses of intramuscular (IM) IDC-G305	Up to 1 year after last vaccination
Secondary	Immunogenicity	The secondary objective is to evaluate the humoral and cellular immunogenicity of multiple ascending doses of intramuscularly administered IDC-G305	Approximately 12 weeks