A Study of OBP-301 With Radiation Therapy in Patients With Esophageal Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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After screening, patients will undergo a combination therapy of OBP-301 with radiation therapy for 6 weeks. At Day 1, Day 18 and Day 32, OBP-301 is directly injected to the location of the lesion. From Day 4, patients receive radiation therapy. Patients will be automatically entered follow-up period for 12 weeks to be observed tolerance and safety. This study is designated as standard 3 + 3 dose escalation study. The first 3 patients will be evaluated with low-dose of OBP-301 and then the study move onto the high-dose cohort of OBP-301. When the DLT (Dose Limiting Toxicity) is observed, 3 more patients will be enrolled in the dose level.

Official Title
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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

Conditions
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Esophageal Cancer

Intervention / Treatment
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* Biological: OBP-301
* Radiation: Radiation


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Patients who have primary tumor or metastatic lesion of histologically or cytologically diagnosed with esophageal carcinoma. Patients are feasible for injection of OBP-301 into target legion Patients aged in 20 to 89 years. Patients with ECOG Performance Status Score ≤ 2. Patient who have life expectancy longer than 12 weeks. Patients who are not applicable to standard therapy. Patients who have adequate organ function. Key Exclusion Criteria: Patients who have an active, treatment-required concomitant malignancy. Patients who had been enrolled within 4 weeks to other clinical trials of unapproved drugs. Patients who have had chemotherapy within 4 weeks. Patients who have treatment history of cancer immunotherapy. Patients who had radiotherapy to treatment targeted lesion. Patients who have active infection which required systemic treatment. Patients who are scored III or IV by NYHA (New York Heart Association). Patients who are judged as inappropriate to this trial by investigator(s).

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OBP-301 + Radiation<br>OBP-301 administration on the Day 1, Day 18 and Day 32 with standard course of radiation(total 60 Gy) for 6 weeks. | Biological: OBP-301<br>* OBP-301 administration on the Day 1, Day 18 and Day 32<br>Radiation: Radiation<br>* Standard radiation therapy for esophageal cancer patient. total 60 Gy for 6 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of Dose Limiting Toxicity | Occurrence of Dose Limiting Toxicity for study period to see safety and tolerability of OBP-301 combined with radiation therapy | 18 weeks | 
| Incidence rate of adverse event | Incidence rate of adverse event for study period to see safety and tolerability of OBP-301 combined with radiation therapy | 18 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor response in the treatment objected lesion | Tumor response in the treatment objected lesion within 18 weeks from the start of treatment. | 18 weeks | 
| Tumor response | Tumor response as the best overall response of the record within 18 weeks from the start of treatment. | 18 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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loco regional, OBP-301, esophageal cancer, radiation, Telomelysin, radiotherapy, oncolytic, virotherapy