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

Pancreas Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04739046
• Other study ID #: SNUBH-IMGPB-2021-02
• Status: Recruiting
• Phase: Phase 2
• Start date: February 1, 2021
• Est. completion date: February 1, 2024

Study information

• Verified date: January 2021
• Source: Seoul National University Bundang Hospital
• Contact: Jin-Hyeok Hwang, MD PhD
• Phone: +82-31-787-7017
• Email: wooltong[@]snu.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: February 1, 2024
• Est. primary completion date: August 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenoviridae Infections
• Pancreas Cancer
• Pancreatic Neoplasms
• Suicide

Intervention

Drug:
• Theragene arm
Theragene®,Ad5-yCD/ mutTKSR39rep-ADP with radiation therapy

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam	Gyeonggi-do

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital	NewGenPharm Incoporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Response Rate	the proportion of patients with advanced or metastatic cancer who have achieved complete response or partial response	24 weeks
Secondary	Disease control rate	the proportion of patients with advanced or metastatic cancer who have achieved complete response, partial response or stable disease	24 weeks
Secondary	Tumor marker test	change of tumor marker in the process of assigned treatment	24 weeks
Secondary	Overall survival	median time from beginning of treatment to death	2 years