Clinical trial · Interventional
A Study of OBP-301 With Radiation Therapy in Patients With Esophageal Cancer
A Phase 1 Study to Evaluate the Safety of OBP-301, Telomelysin in Combination With Radiation Therapy in Patients With Esophageal Cancer Not Applicable for Standard Therapy
NCT03213054CI-TRIAL-00035040unknownPhase 1ClinicalTrials.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 phase 1 study to evaluate safety and tolerability of Telomelysin (OBP-301) in combination with radiation therapy in patient with esophageal cancer who are not applicable 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 |
|---|---|---|---|
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| OBP-301 | Biological | — | UNRESOLVED |
| Radiation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- OBP-301 + Radiation
- description
- OBP-301 administration on the Day 1, Day 18 and Day 32 with standard course of radiation(total 60 Gy) for 6 weeks.
- interventionNames
- Biological: OBP-301
- Radiation: Radiation
Primary outcomes (2)
- measure
- Occurrence of Dose Limiting Toxicity
- timeFrame
- 18 weeks
- description
- Occurrence of Dose Limiting Toxicity for study period to see safety and tolerability of OBP-301 combined with radiation therapy
- measure
- Incidence rate of adverse event
- timeFrame
- 18 weeks
- description
- Incidence rate of adverse event for study period to see safety and tolerability of OBP-301 combined with radiation therapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 89 Years
Show eligibility criteria text
Key Inclusion Criteria: 1. Patients who have primary tumor or metastatic lesion of histologically or cytologically diagnosed with esophageal carcinoma. 2. Patients are feasible for injection of OBP-301 into target legion 3. Patients aged in 20 to 89 years. 4. Patients with ECOG Performance Status Score ≤ 2. 5. Patient who have life expectancy longer than 12 weeks. 6. Patients who are not applicable to standard therapy. 7. Patients who have adequate organ function. Key Exclusion Criteria: 1. Patients who have an active, treatment-required concomitant malignancy. 2. Patients who had been enrolled within 4 weeks to other clinical trials of unapproved drugs. 3. Patients who have had chemotherapy within 4 weeks. 4. Patients who have treatment history of cancer immunotherapy. 5. Patients who had radiotherapy to treatment targeted lesion. 6. Patients who have active infection which required systemic treatment. 7. Patients who are scored III or IV by NYHA (New York Heart Association). 8. Patients who are judged as inappropriate to this trial by investigator(s).
References
Publications (0)
Data not yet available
No reference posted for this study.