A Phase 1 Trial of NY-ESO-1 With GLA-SE in Patients With Unresectable or Metastatic Cancer
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.
Checked against the public recordLast updated Aug 17, 2017 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- Immune Design, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
- Interventions being studied
- Biological: IDC-G305
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Scottsdale HealthcareScottsdale, Arizona
- H. Lee Moffitt Cancer CenterTampa, Florida
- Karmanos Cancer InstituteDetroit, Michigan
- Roswell Park Cancer InstituteBuffalo, New York
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Aug 17, 2017. Always confirm current availability with the study team.