NCT06693986 · Masonic Cancer Center, University of Minnesota
Adenovirus (RGDCRAdCOX2F)
What this study is about
This is a single center, Phase I dose finding study of a single direct tumor injection of an RGD modified conditionally replicative adenovirus (RGDCRAdcox2F) in persons with adenocarcinoma of the pancreas. The study is designed to determine the MTD of RGDCRAdCOX2F that corresponds to the maximum desired toxicity of ≤ 20%.
View original scientific description
This is a single center, Phase I dose finding study of a single direct tumor injection of an RGD modified conditionally replicative adenovirus (RGDCRAdcox2F) in persons with adenocarcinoma of the pancreas. The study is designed to determine the MTD of RGDCRAdCOX2F that corresponds to the maximum desired toxicity of ≤ 20%.
Interventions
BIOLOGICAL
Replicative Adenovirus Vector (RGDCRAdCOX2F)
RGDCRAdcox2F (RGD) is a "local" product and is provided through this study.
Primary outcome measures
Number of Participants Experiencing Dose Limiting Toxicity (DLT) Events
Time frame: 2 years
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Histologically documented pancreatic adenocarcinoma that is confined to the pancreas and regional lymph nodes after staging by CT or MRI and endoscopic ultrasound.
- One prior line of therapy is permitted (i.e. neo-adjuvant therapy); however, at least 4 weeks must have elapsed between the last dose of drug and the injection of RGDCRAdCOX2F.
- Must be able to tolerate esophagogastroduodenoscopy (EGD) and the tumor must be accessible by endoscopic ultra sound. Participants will be excluded if obtaining biopsies are deemed unsafe or not feasible.
- Age 18 years of age or older at the time of consent
- Normal cardiac and pulmonary function based on history and physical exam
- Participants with partners of childbearing potential must be willing to use at least two forms of effective birth control (one form must be a barrier method) for at least 1 month after Day 1.
Exclusion criteria
- Pregnant or breastfeeding. Persons of child-bearing potential must have a negative pregnancy test (serum or urine) with 14 days of study enrollment.
- Other pancreatic malignancies (e.g., neuroendocrine tumors and mucinous cystic) and adenocarcinomas of the ampulla, bile ducts, and duodenum.
- Tumors in mucosal regions or close to an airway, major blood vessel, or spinal cord that in the opinion of the enrolling investigator could cause occlusion or compression in the case of tumor swelling or erosion into a major vessel in the case of necrosis.
- Known history of human immunodeficiency virus (HIV) infection
- Known history of or active acute or chronic active hepatitis B or C infection
- Serious concurrent infection or medical illness, which in the enrolling investigator's opinion would jeopardize the ability of the participant to receive the treatment outlined in this protocol with reasonable safety.
- Requires immunosuppression ≥10mg/day of prednisone for more than 1 week.
- History of or active known or suspected autoimmune disease, or a syndrome that requires systemic or immunosuppressive agents.
- Disease beyond the regional lymph nodes
- Active diffuse pancreatitis
- Active inflammatory conditions
- Prior gastrojejunostomy
Where
- Minneapolis, Minnesota
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 7, 2026 · Source of record for eligibility and locations