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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Immune Design
ClinicalTrials.gov Identifier:
NCT02015416
First received: December 13, 2013
Last updated: February 2, 2015
Last verified: February 2015
  Purpose
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.

Condition Intervention Phase
Melanoma
Ovarian Cancer
Sarcoma
Non-small Cell Lung Cancer
Breast Cancer
Biological: IDC-G305
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Immune Design:

Primary Outcome Measures:
  • Safety and tolerability [ Time Frame: Up to 1 year after last vaccination ] [ Designated as safety issue: Yes ]
    To evaluate the safety and tolerability of multiple ascending doses of intramuscular (IM) IDC-G305


Secondary Outcome Measures:
  • Immunogenicity [ Time Frame: Approximately 12 weeks ] [ Designated as safety issue: No ]
    The secondary objective is to evaluate the humoral and cellular immunogenicity of multiple ascending doses of intramuscularly administered IDC-G305


Estimated Enrollment: 30
Study Start Date: November 2013
Estimated Study Completion Date: August 2015
Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IDC-G305
NY-ESO-1 recombinant protein together with GLA-SE
Biological: IDC-G305
NY-ESO-1 recombinant protein together with GLA-SE

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02015416

Locations
United States, Arizona
Scottsdale Healthcare
Scottsdale, Arizona, United States, 85258
United States, Florida
H. Lee Moffitt Cancer Center
Tampa, Florida, United States, 33612
United States, Michigan
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Sponsors and Collaborators
Immune Design
Investigators
Principal Investigator: Kunle Odunsi, MD PhD Roswell Park Cancer Institute
  More Information

Responsible Party: Immune Design
ClinicalTrials.gov Identifier: NCT02015416     History of Changes
Other Study ID Numbers: IDC-G305-2013-001 
Study First Received: December 13, 2013
Last Updated: February 2, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Immune Design:
Melanoma
Ovarian cancer
Sarcoma
Non-small cell lung cancer
NSCLC
Breast cancer

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Melanoma
Sarcoma
Ovarian Neoplasms
Neoplasm Metastasis
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Neoplasms, Connective and Soft Tissue
Endocrine Gland Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplastic Processes

ClinicalTrials.gov processed this record on December 02, 2016