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

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