NCT04739046

An Exploratory Trial to Evaluate Efficacy and Safety for Combination Treatment of Adenovirus Double Suicide Gene Therapy

A Single Arm, Open, Exploratory Clinical Trial to Evaluate Efficacy and Safety for Combination Treatment of Replication Competent Adenovirus Double Suicide Gene Therapy(Theragene®,Ad5-yCD/mutTKSR39rep-ADP) and Radiation Therapy in Patients

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Seoul National University Bundang Hospital · Academic / Other
• Sex: All
• Age: 19 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Replication-competent Adenovirus-mediated Double Suicide Gene Therapy (Theragene®,Ad5-yCD/mutTKSR39rep-ADP) showed safety and anti-cancer effect in patients with pancreatic cancer in phase I study. From the experience of phase I study, the safety and efficacy of combination with standard chemotherapy and radiation therapy with Theragene treatment will be assessed in this study.

Detailed description

Phase IIa study of Replication-competent Adenovirus-mediated Double Suicide Gene Therapy (Theragene®,Ad5-yCD/mutTKSR39rep-ADP) with radiation therapy

Conditions

• Pancreas Cancer

Interventions

Type	Name	Description
DRUG	Theragene arm	Theragene®,Ad5-yCD/ mutTKSR39rep-ADP with radiation therapy

Timeline

• Start date: 2021-02-01
• Primary completion: 2022-08-01
• Completion: 2024-02-01
• First posted: 2021-02-04
• Last updated: 2021-03-17

Locations

1 site across 1 country: South Korea