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

NCT04739046 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2021-03-17

No results posted yet for this study

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.

Conditions

  • Pancreas Cancer

Interventions

DRUG

Theragene arm

Theragene®,Ad5-yCD/ mutTKSR39rep-ADP with radiation therapy

Sponsors & Collaborators

  • NewGenPharm Incoporation

    collaborator UNKNOWN

  • Seoul National University Bundang Hospital

    lead OTHER

Principal Investigators

  • Jin-Hyeok Hwang, MD PhD · Seoul National University Bundang Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-01
Primary Completion
2022-08-01
Completion
2024-02-01

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04739046 on ClinicalTrials.gov