NCT03213054

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Oncolys BioPharma Inc · Industry
• Sex: All
• Age: 20 Years – 89 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Esophageal Cancer

Interventions

Type	Name	Description
BIOLOGICAL	OBP-301	OBP-301 administration on the Day 1, Day 18 and Day 32
RADIATION	Radiation	Standard radiation therapy for esophageal cancer patient. total 60 Gy for 6 weeks

Timeline

• Start date: 2017-07-07
• Primary completion: 2019-03-01
• Completion: 2019-06-01
• First posted: 2017-07-11
• Last updated: 2018-09-26

Locations

2 sites across 1 country: Japan

Regulatory

• FDA-regulated drug study