Pancreas CancerPhase 2NCT04739046
An Exploratory Trial to Evaluate Efficacy and Safety for Combination Treatment of Adenovirus Double Suicide Gene Therapy
A Phase 2 study testing Theragene arm in people with Pancreas Cancer, run by Seoul National University Bundang Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- Pancreas Cancer
- What is being tested?
- Theragene arm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Feb 2021to 1 Feb 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707
Jin-Hyeok Hwang, MD PhD, +82-31-787-7017
About this study
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
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.
Read the 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
- Being tested
- Theragene arm
- Keywords
- pancreatic cancer, radiation therapy, adenovirus, gene therapy
- Medical subject headings
- Pancreatic Neoplasms, Adenoviridae Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Theragene armDrug
Theragene®,Ad5-yCD/ mutTKSR39rep-ADP with radiation therapy
| Study group | Role | What they receive |
|---|---|---|
| Theragene arm | Experimental | Patients who were treated with Theragene®,Ad5-yCD/mutTKSR39rep-ADP and radiation therapy Receives: Drug: Theragene arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate
the proportion of patients with advanced or metastatic cancer who have achieved complete response or partial response
Measured: 24 weeks
Secondary outcomes (3)
Disease control rate
the proportion of patients with advanced or metastatic cancer who have achieved complete response, partial response or stable disease
Measured: 24 weeks
Tumor marker test
change of tumor marker in the process of assigned treatment
Measured: 24 weeks
Overall survival
median time from beginning of treatment to death
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2021
- Study start1 Feb 2021
- Primary completion1 Aug 2022 (estimated)
- Study completion1 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreas CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- NewGenPharm Incoporation
- Responsible party
- Sponsor
- Investigators
- Jin-Hyeok Hwang, MD PhD, Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04739046
- Sponsor's protocol ID
- SNUBH-IMGPB-2021-02
- Status last verified
- Jan 2021
- First submitted
- 1 Feb 2021
- Last updated
- 17 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04739046
- Acronym / sponsor ID
- SNUBH-IMGPB-2021-02
- Conditions
- Pancreas Cancer
- Keywords
- pancreatic cancer, radiation therapy, adenovirus, gene therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Collaborators
- NewGenPharm Incoporation
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 1 Aug 2022 (estimated)
- Study completion
- 1 Feb 2024 (estimated)
- First posted
- 4 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Theragene arm | Experimental | Drug: Theragene armPatients who were treated with Theragene®,Ad5-yCD/mutTKSR39rep-ADP and radiation therapy |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Theragene armTheragene®,Ad5-yCD/ mutTKSR39rep-ADP with radiation therapy | Drug | Theragene arm |
Primary outcome
Objective Response Rate
Time frame: 24 weeks
the proportion of patients with advanced or metastatic cancer who have achieved complete response or partial response
3 secondary outcomes
Disease control rate
Time frame: 24 weeks
Tumor marker test
Time frame: 24 weeks
Overall survival
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jin-Hyeok Hwang, MD PhD principal investigator
Seoul National University Bundang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Theragene arm in people with Pancreas Cancer, run by Seoul National University Bundang Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jin-Hyeok Hwang, MD PhD (+82-31-787-7017, wooltong@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2021; AzTrials last refreshed its copy on 31 Oct 2026.