NCT02293850

Phase I Study to Evaluate the Safety and Efficacy of Telomelysin (OBP-301) in Patients With Hepatocellular Carcinoma

A Phase I Study to Evaluate the Safety and Efficacy of Telomelysin (OBP-301) in Patients With Hepatocellular Carcinoma

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: Oncolys BioPharma Inc · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is an open labeled, multiple centers, two countries (Taiwan and Korea) non-comparative phase I trial in patients with hepatocellular carcinoma. In phase I part, a maximum of 18 patients will be recruited in this study.

Detailed description

After screening, each eligible patient will undergo a treatment of OBP-301 within 14 days and will automatically enter follow-up period. The follow-up period is up to 12 weeks after the last injection in the phase I part. Each patient will return for follow-up visit weekly in the first month after the last injection, and then every 4 weeks up to the end of follow-up period.

Conditions

• Carcinoma, Hepatocellular

Interventions

Type	Name	Description
BIOLOGICAL	OBP-301	A range of dose levels is investigated and the starting dose is 1x1010 VP/tumor. Dose administration will be conducted through a dose-escalating scheme from 1x1010 VP/tumor to 1x1011 VP/tumor, 1x1012 VP/tumor, 3x1011 VP/tumor and 3x1012 VP/tumor.

Timeline

• Start date: 2014-10-01
• Primary completion: 2019-04-01
• Completion: 2021-04-01
• First posted: 2014-11-18
• Last updated: 2018-08-20

Locations

2 sites across 2 countries: South Korea, Taiwan