Phase I Study of RGDCRAdCOX2F for Pancreatic Adenocarcinoma

This study is testing a treatment called RGDCRAdCOX2F, which is a modified virus, for people with adenocarcinoma of the pancreas. This is a Phase I study, which means it's focused on finding a safe dose. You might be able to join if your pancreatic cancer is confined to the pancreas and nearby lymph nodes, and you've had no more than one prior treatment. The main goal is to see how many participants experience dose-limiting side effects (toxicity) over two years. The study is currently unclear on its recruitment status and plans to enroll 18 participants.

Study design
This is a single-center, Phase I study that will involve a single injection of the treatment. It aims to find the maximum safe dose of RGDCRAdCOX2F in about 18 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be monitored for dose-limiting side effects for two years.

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NCT06693986

Adenovirus (RGDCRAdCOX2F)

Recruiting
PHASE1Ages 18+InterventionalTreatment
Masonic Cancer Center, University of Minnesota
~18 participants
Updated 2026-01-07 on ClinicalTrials.gov
What's tested:Replicative Adenovirus Vector (RGDCRAdCOX2F)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Participants Experiencing Dose Limiting Toxicity (DLT) Events
Measured over 2 years
Adenocarcinoma of Pancreas
1 sites across 1 states
Minnesota1

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Eligibility criteria

Inclusion

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

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
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
  • Number of Participants Experiencing Dose Limiting Toxicity (DLT) Events2 years