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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Research site
Kashima-shi, Chiba, Japan
RECRUITINGResearch site
Kita, Okayama-ken, Japan
RECRUITINGOccurrence of Dose Limiting Toxicity
Occurrence of Dose Limiting Toxicity for study period to see safety and tolerability of OBP-301 combined with radiation therapy
Time frame: 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
Time frame: 18 weeks
Tumor response in the treatment objected lesion
Tumor response in the treatment objected lesion within 18 weeks from the start of treatment.
Time frame: 18 weeks
Tumor response
Tumor response as the best overall response of the record within 18 weeks from the start of treatment.
Time frame: 18 weeks
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