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Recruiting

NCT Number: NCT06693986

Adenovirus (RGDCRAdCOX2F)

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%.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Masonic Cancer Center

Minneapolis, Minnesota, 55455, United States

Location status: Recruiting

Location contact

Edward Greeno, MD

CONTACT

612-626-6418

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Replicative Adenovirus Vector (RGDCRAdCOX2F)

Biological

RGDCRAdcox2F (RGD) is a "local" product and is provided through this study.

Primary outcomes

  1. Number of Participants Experiencing Dose Limiting Toxicity (DLT) Events

    Time frame: 2 years

Study contacts

Contact information is provided by the study sponsor or research team.

Edward Greeno, MD

CONTACT

[email protected]

612-626-6418

Sponsors and collaborators

Lead sponsor

Masonic Cancer Center, University of Minnesota

Other

Registry information

Official study title

A Phase I Study of a Tropism Modified Conditionally Replicative Adenovirus Vector (RGDCRAdCOX2F) for Endoscopic, Direct-Tumor Delivery in Pancreatic Adenocarcinoma

Important dates

Study start
2024
Primary completion
2028
Study completion
2029
First posted
Nov 19, 2024
Registry last updated
Jan 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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