RecruitingPhase 1NCT06693986

Adenovirus (RGDCRAdCOX2F)

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


Sponsor

Masonic Cancer Center, University of Minnesota

Enrollment

18 participants

Start Date

Dec 27, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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%.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a modified virus (called RGDCRAdCOX2F) injected directly into pancreatic tumors using an endoscopic ultrasound procedure. The virus is engineered to selectively infect and kill cancer cells. This is an early-phase study focused on safety in patients with pancreatic cancer confined to the pancreas and nearby lymph nodes. **You may be eligible if...** - You are 18 or older - You have been diagnosed with pancreatic adenocarcinoma (confirmed by tissue biopsy) that is confined to the pancreas and regional lymph nodes - You have normal heart and lung function - You may have had one prior treatment (neo-adjuvant therapy), but at least 4 weeks must have passed since your last dose - Your tumor is accessible via endoscopic ultrasound - You are willing and able to use effective contraception if of childbearing potential **You may NOT be eligible if...** - You are pregnant or breastfeeding - You have another type of pancreatic tumor (such as a neuroendocrine tumor) or cancer of the bile duct or duodenum - Your tumor is located near vital structures (airways, major blood vessels, or spinal cord) where swelling could be dangerous - You have HIV or other serious immune conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALReplicative Adenovirus Vector (RGDCRAdCOX2F)

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


Locations(1)

Masonic Cancer Center

Minneapolis, Minnesota, United States

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NCT06693986