Clinical trial · Interventional
A Phase 1 Trial of NY-ESO-1 With GLA-SE in Patients With Unresectable or Metastatic Cancer
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Sarcoma | Sarcoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IDC-G305 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- IDC-G305
- description
- NY-ESO-1 recombinant protein together with GLA-SE
- interventionNames
- Biological: IDC-G305
Primary outcomes (1)
- measure
- Safety and tolerability
- timeFrame
- Up to 1 year after last vaccination
- description
- To evaluate the safety and tolerability of multiple ascending doses of intramuscular (IM) IDC-G305
Secondary outcomes (1)
- measure
- Immunogenicity
- timeFrame
- Approximately 12 weeks
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available