Clinical trial · Interventional
Safety and Efficacy Study of Epitope Peptide To Treat HLA-A*24 or A*02-positive Advanced Solid Tumors
Phase I/II Study Using Epitope Peptide Restricted to HLA-A*24 or HLA-A*02 in Patients With Advanced Solid Tumors That Are Refractory to Standard Therapy
NCT01949688CI-TRIAL-00037689completedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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)
In this study, the investigators examine using a combination of two types of HLA-A\*2402 (or HLA-A\*0201)-restricted epitope peptides, which were derived from VEGF-R1 and VEGF-R2 the safety, immunogenicity, and antitumor effect of vaccine treatment for advanced solid tumor patients who are refractory to standard therapy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HLA-A*2402 or A*0201 restricted peptides | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- HLA-A*2402 restricted peptides
- description
- HLA-A\*2402 restricted peptides with adjuvant
- interventionNames
- Biological: HLA-A*2402 or A*0201 restricted peptides
- type
- EXPERIMENTAL
- label
- HLA-A*0201 restricted peptides
- description
- HLA-A\*0201 restricted peptides with adjuvant
- interventionNames
- Biological: HLA-A*2402 or A*0201 restricted peptides
Primary outcomes (2)
- measure
- Evaluation of safety: the number of adverse events of vaccination therapy.
- timeFrame
- 2 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: 1. Advanced solid tumors that are refractory to standard therapies or that cannot be treated with those due to medical reason. 2. ECOG performance status 0-1 3. Age between 20 to 85 4. Clinical efficacy can be evaluated by some methods 5. No prior chemotherapy, radiation therapy, hyperthermia or immunotherapy within two weeks 6. Life expectancy \> 3 months 7. Laboratory values as follows 1500/mm3 \< WBC \< 10000/mm3 Platelet count \> 75000/mm3 15% \< Lymphcyte fraction Asparate transaminase \< 3 X cutoff value Alanine transaminase \< 3 X cutoff value Total bilirubin \< 3 X cutoff value Serum creatinine \< 2X cutoff value 8. HLA-A\*2402 or HLA-A\*0201 9. Able and willing to give valid written informed consent Exclusion Criteria: 1. Active and uncontrolled cardiac disease (i.e. coronary syndromes, arrhythmia) 2. Myocardial infarction within six months before entry 3. Breastfeeding and Pregnancy (woman of child bearing potential) 4. Active and uncontrolled infectious disease 5. Concurrent treatment with steroids or immunosuppressing agent 6. Other malignancy requiring treatment 7. Non-cured traumatic wound 8. Decision of unsuitableness by principal investigator or physician-in-charge
References
Publications (0)
Data not yet available
No reference posted for this study.