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Study of vvDD-hIL2-2-RG-1 for Metastatic Gastrointestinal and Peritoneal Tumors

This study is testing an experimental drug called vvDD-hIL2-2-RG-1 for people with metastatic gastrointestinal (stomach, esophagus, colon, rectum, liver, pancreas) and peritoneal (lining of the abdomen) tumors. This drug is a modified virus designed to target and destroy cancer cells by boosting your body's immune system. Researchers want to find out how safe vvDD-hIL2-2-RG-1 is and what dose works best. You might be able to join if you are 18-69 years old, have specific tumor markers (MSI and KRAS), and standard chemotherapy hasn't worked or isn't an option. The study will look at side effects and how your tumors respond to the treatment. The current status of this study is unclear.

Study design
This is a Phase I, open-label study, meaning both you and the study team will know which treatment you are receiving. It will involve a single dose of the drug and will gradually increase the dose in groups of 3 to 6 participants.
What's involved
You will receive one injection of vvDD-hIL2-2-RG-1 directly into your tumor. The study team will monitor you for side effects for at least 28 days after the injection.
Compensation
Not stated in the trial record.
Follow-up
Your safety will be monitored for a maximum of 28 days after receiving the injection.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07001592

Intra-tumoral (IT) Injection of vvDD-hIL2-2-RG-1 for Metastatic Gastrointestinal and Peritoneal Tumors

Recruiting
PHASE1Ages 18–69InterventionalTreatment
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
~18 participants
Updated 2025-06-03 on ClinicalTrials.gov
What's tested:vvDD-hIL-2-RG-1

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of Treatment-Emergent Adverse Events (Safety) of vvDD-hIL-2-RG-1
Measured over maximum 28 days
+2 more outcomes measured

Conditions

Gastric Neoplasms
Esophageal Cancer
Liver Cancer
Liver Metastasis
MSS-CRC
MSS
Gastric Adenocarcinoma
Peritoneal Cancer
Peritoneal Carcinoma
Peritoneal Metastases
MSI-H
Gastric Cancer

Explore related trials

Esophageal CarcinomaGastric CarcinomaLiver CarcinomaMalignant Peritoneal NeoplasmGTPase KRasMSI1 Gene

Where it's being run

1 sites across 1 states
Pennsylvania1

Study leadership

  • Patrick Wagner, MD · PRINCIPAL_INVESTIGATOR · Allegheny Health Network

Who to contact

Patrick Wagner, MD
[email protected]
412-359-3731
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Exclusion

New York Heart Association functional class III-IV heart failure on active treatment
Pulse oximetry of \< 90% in room air at rest 7. Subjects who have received radiation, chemotherapy or other potentially immunosuppressive therapy within 2 weeks prior to study screening and within 4 weeks prior to anticipated vvDD-hIL-2-RG-1 treatment. 8. Experienced a severe systemic reaction or side-effect as a result of a previous smallpox vaccination. 9. Subjects who, in the opinion of the Investigator, have a medical condition that would subject the subject to prohibitive risk by participation in this study, or who may be unable to safely complete the required tumor biopsies. 10. Subjects with household contacts who are children \< 5 years old, have active eczema, psoriasis or other inflammatory skin conditions or have a significant immunodeficiency due to underlying illness (e.g. human immunodeficiency virus) and/or medication (e.g. systemic corticosteroids) will be excluded unless alternate living arrangements can be made during the subject's active dosing period and for three weeks following the study medication. 11. Vaccination with a live virus in the previous 60 days prior to Day 0. 12. Inability or unwillingness to give informed consent. 13. Is unable or unwilling to comply with protocol follow-up requirements. -

What this trial measures

  • Incidence of Treatment-Emergent Adverse Events (Safety) of vvDD-hIL-2-RG-1maximum 28 days

    Measured by frequency and severity of adverse events (AEs) at each dose level as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

  • Maximally-tolerated dose (MTD) of vvDD-hIL-2-RG-1maximum 28 days

    Determined by measuring the number of AEs and DLTs at each dose level

  • Maximum-feasible dose (MFD) of vvDD-hIL-2-RG-1maximum 28 days

    Determined by measuring the number of AEs and DLTs at each dose level