NCT06693986RecruitingPhase 1
Adenovirus (RGDCRAdCOX2F)
A Phase I Study of a Tropism Modified Conditionally Replicative Adenovirus Vector (RGDCRAdCOX2F) for Endoscopic, Direct-Tumor Delivery in Pancreatic Adenocarcinoma
Source: ClinicalTrials.gov · Last updated 7 Jan 2026
Brief summary (registry, in English)
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%.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 18 (estimated)
- First submitted
- 15 Nov 2024
- Start date
- 27 Dec 2024
- Primary completion date
- 15 Oct 2028
- Lead sponsor
- Masonic Cancer Center, University of Minnesota
- Diseases
- Pancreatic cancer
- NCT number
- NCT06693986
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 18
- From 27 Dec 2024 to the primary completion date, 15 Oct 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- Prior gastrojejunostomy
Other illness
- Other pancreatic malignancies (e.g., neuroendocrine tumors and mucinous cystic) and adenocarcinomas of the ampulla, bile ducts, and duodenum.
- Known history of human immunodeficiency virus (HIV) infection
- Known history of or active acute or chronic active hepatitis B or C infection
- 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 inflammatory conditions
Lab values
- Pregnant or breastfeeding. Persons of child-bearing potential must have a negative pregnancy test (serum or urine) with 14 days of study enrollment.
Other
- 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.
- Requires immunosuppression ≥10mg/day of prednisone for more than
- 1 week.
- Active diffuse pancreatitis
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Masonic Cancer Center Coordinator of this site? Confirm its status | Minneapolis | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.