Clinical trial · Interventional
PhaseⅠ/Ⅱ Study of URLC10-177 and TTK-567 Peptide Vaccine Combined With CpG7909 in Patients With Esophageal Cancer
Phase I/II Study of URLC10-177 and TTK-567, Novel Tumor Specific Epitope Peptides Restricted to HLA-A*2402 Derived From Tumor Associated Antigens, Combined With CpG7909, a TLR9 Agonist, in Patients With Advanced or Recurrent Esophageal Cancer.
NCT00669292CI-TRIAL-00003895unknownPhase 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)
This is a single institution phase I / II trial to evaluate the safety and efficacy of URLC10-177 and TTK-567 emulsified with Montanide ISA 51 in combination with different doses of CpG7909 in patients with advanced or recurrent esophageal cancer.
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 |
|---|---|---|---|
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| URLC10-177, TTK-567, CpG-7909 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Safety(Phase I:toxicities as assessed by NCI CTCAE version3) and efficacy(Phase II:Feasibility as evaluated by RECIST)
- timeFrame
- 2 months
Secondary outcomes (6)
- measure
- To evaluate immunological responses (Phase I/II)
- timeFrame
- 2months
- measure
- To determine the recommended phase II dose of CpG7909(Phase I)
- timeFrame
- 2months
- measure
- To determine the clinical effectiveness in the patients with measurable disease(Phase I)
- timeFrame
- 2months
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: DISEASE CHARACTERISTICS 1. locally advanced or metastatic esophageal cancer precluding curative surgical resection and recurrent esophageal cancer 2. measurable disease by CT scan PATIENT CHARACTERISTICS 1. ECOG performance status 0-1 2. Life expectancy \> 3 months 3. Laboratory values as follows * 2000/mm3 \< WBC \< 15000/mm3 * Platelet count \> 75000/mm3 * Aspartate transaminase \< 150 IU/L * Alanine transaminase \< 150 IU/L * Creatinine \< 2.0 mg/dl 4. HLA-A\*2402 5. Able and willing to give valid written informed consent Exclusion Criteria: 1. Pregnancy(woman of childbearing potential:Refusal or inability to use effective means of contraception) 2. Breastfeeding 3. Active or uncontrolled infection 4. Concurrent treatment with steroids or immunosuppressing agent 5. Prior chemotherapy,radiation therapy, or immunotherapy within 4 weeks 6. Clinically significant heart disease 7. Decision of unsuitableness by principal investigator or physician-in-charge
References
Publications (1)
- DERIVEDIwahashi M, Katsuda M, Nakamori M, Nakamura M, Naka T, Ojima T, Iida T, Yamaue H. Vaccination with peptides derived from cancer-testis antigens in combination with CpG-7909 elicits strong specific CD8+ T cell response in patients with metastatic esophageal squamous cell carcinoma. Cancer Sci. 2010 Dec;101(12):2510-7. doi: 10.1111/j.1349-7006.2010.01732.x. Epub 2010 Sep 28. PMID 20874827