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.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
The study team can explain what participation involves.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Aug 17, 2017 · Source: ClinicalTrials.gov
Ask the study team to confirm whether enrollment is open.
Interventional
Locations may change over time.
Study sponsor
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
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- 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
- 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.