Neoplasms

Digestive System Diseases

All Conditions

Rare Diseases

Esophageal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Head and Neck Neoplasms

Gastrointestinal Diseases

Esophageal Diseases

Esophageal Cancer

OBP-301 administration on the Day 1, Day 18 and Day 32 with standard course of radiation(total 60 Gy) for 6 weeks.

OBP-301 administration on the Day 1, Day 18 and Day 32

OBP-301

Standard radiation therapy for esophageal cancer patient. total 60 Gy for 6 weeks

Radiation

Yira Bermudez, PhD, MBA, RAC

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.

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

Occurrence of Dose Limiting Toxicity for study period to see safety and tolerability of OBP-301 combined with radiation therapy

Incidence rate of adverse event for study period to see safety and tolerability of OBP-301 combined with radiation therapy

Tumor response in the treatment objected lesion within 18 weeks from the start of treatment.

Tumor response as the best overall response of the record within 18 weeks from the start of treatment.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Study of OBP-301 With Radiation Therapy in Patients With Esophageal Cancer	NCT03213054	Esophageal Canc...	OBP-301 Radiation	20 Years - 89 Years	Oncolys BioPharma Inc
A Study of OBP-301 With Radiation Therapy in Patients With Esophageal Cancer	NCT03213054	Esophageal Canc...	OBP-301 Radiation	20 Years - 89 Years	Oncolys BioPharma Inc

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