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

Primary Purpose

Pancreas Cancer

Status

Recruiting

Phase

Phase 2

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Theragene arm

About this trial

This is an interventional treatment trial for Pancreas Cancer focused on measuring pancreatic cancer, radiation therapy, adenovirus, gene therapy

Eligibility Criteria

19 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients with borderline resectable or locally advanced pancreatic cancer
Patients with histologically confirmed pancreatic adenocarcinoma
Patients with no evidence of peritoneal or hematogenous metastasis
Patients with ECOG performance status 0-1
Patients with renal function (Serum creatinine ≤ 1.5 mg/dL or creatinine clearance ≥ 50 mL/min/m²)
Patients with bone marrow function (WBC > 4,000/uL or absolute neutrophil count ≥ 1500/uL, PLT ≥ 100,000/uL, and Hemoglobin > 10 g/dL)
Patients with liver function (Bilirubin < 2.0 mg/dL and SGOT and SGPT < 3 times upper limit of normal (ULN))
Patients with agreement with informed consent

Exclusion Criteria:

Patients with a history of other cancer
Patients with recurred pancreatic cancer
Patients with a history of radiation on more than 25% of bone marrow
Patients with a history of major surgery except laparoscopic examination, endoscopic intervention, or gastrojejunostomy
Patients who have contraindication of radiation therapy
Patients with HIV infection, chronic hepatitis B, chronic hepatitis C, or liver cirrhosis
Female patients with childbearing age or pregnancy or breast feeding
Patients who are considered as inappropriate candidate by investigators

Sites / Locations

Seoul National University Bundang HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Theragene arm

Arm Description

Patients who were treated with Theragene®,Ad5-yCD/mutTKSR39rep-ADP and radiation therapy

Outcomes

Primary Outcome Measures

Objective Response Rate

the proportion of patients with advanced or metastatic cancer who have achieved complete response or partial response

Secondary Outcome Measures

Disease control rate

the proportion of patients with advanced or metastatic cancer who have achieved complete response, partial response or stable disease

Tumor marker test

change of tumor marker in the process of assigned treatment

Overall survival

median time from beginning of treatment to death

Full Information

NCT ID

NCT04739046

First Posted

February 1, 2021

Last Updated

March 15, 2021

Sponsor

Seoul National University Bundang Hospital

Collaborators

NewGenPharm Incoporation

1. Study Identification

Unique Protocol Identification Number

NCT04739046

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2021

Overall Recruitment Status

Recruiting

Study Start Date

February 1, 2021 (Actual)

Primary Completion Date

August 1, 2022 (Anticipated)

Study Completion Date

February 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Seoul National University Bundang Hospital

Collaborators

NewGenPharm Incoporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pancreas Cancer

Keywords

pancreatic cancer, radiation therapy, adenovirus, gene therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Theragene arm

Arm Type

Experimental

Arm Description

Patients who were treated with Theragene®,Ad5-yCD/mutTKSR39rep-ADP and radiation therapy

Intervention Type

Drug

Intervention Name(s)

Theragene arm

Intervention Description

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

Primary Outcome Measure Information:

Title

Objective Response Rate

Description

the proportion of patients with advanced or metastatic cancer who have achieved complete response or partial response

Time Frame

24 weeks

Secondary Outcome Measure Information:

Title

Disease control rate

Description

the proportion of patients with advanced or metastatic cancer who have achieved complete response, partial response or stable disease

Time Frame

24 weeks

Title

Tumor marker test

Description

change of tumor marker in the process of assigned treatment

Time Frame

24 weeks

Title

Overall survival

Description

median time from beginning of treatment to death

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients with borderline resectable or locally advanced pancreatic cancer Patients with histologically confirmed pancreatic adenocarcinoma Patients with no evidence of peritoneal or hematogenous metastasis Patients with ECOG performance status 0-1 Patients with renal function (Serum creatinine ≤ 1.5 mg/dL or creatinine clearance ≥ 50 mL/min/m²) Patients with bone marrow function (WBC > 4,000/uL or absolute neutrophil count ≥ 1500/uL, PLT ≥ 100,000/uL, and Hemoglobin > 10 g/dL) Patients with liver function (Bilirubin < 2.0 mg/dL and SGOT and SGPT < 3 times upper limit of normal (ULN)) Patients with agreement with informed consent Exclusion Criteria: Patients with a history of other cancer Patients with recurred pancreatic cancer Patients with a history of radiation on more than 25% of bone marrow Patients with a history of major surgery except laparoscopic examination, endoscopic intervention, or gastrojejunostomy Patients who have contraindication of radiation therapy Patients with HIV infection, chronic hepatitis B, chronic hepatitis C, or liver cirrhosis Female patients with childbearing age or pregnancy or breast feeding Patients who are considered as inappropriate candidate by investigators

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jin-Hyeok Hwang, MD PhD

Phone

+82-31-787-7017

wooltong@snu.ac.kr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jin-Hyeok Hwang, MD PhD

Organizational Affiliation

Seoul National University Bundang Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Seoul National University Bundang Hospital

City

Seongnam

State/Province

Gyeonggi-do

ZIP/Postal Code

463-707

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jin-Hyeok Hwang, MD PhD

Phone

+82-31-787-7017

12. IPD Sharing Statement

Learn more about this trial

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

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