Actively Recruiting
A Phase I Dose-Escalation Trial of vvDD-hIL2-2-RG-1 Administered by Intra-tumoral Injection for Metastatic Gastrointestinal and Peritoneal Tumors
Led by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) · Updated on 2025-06-03
18
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research study focuses on patients with advanced abdominal cancers, such as metastatic gastrointestinal tumors including esophageal, gastric, colon, rectal, liver, and pancreatic cancers. It aims to evaluate the safety and find the best dose of a new experimental drug called vvDD-hIL2, which is a genetically modified vaccinia virus designed to stimulate the immune system to target and destroy tumors while minimizing harm to healthy tissue. This Phase I trial is open-label and involves patients who have not responded to standard chemotherapy or immunotherapy. Participants will receive a single injection of vvDD-hIL2 directly into their abdominal tumors at one of three dose levels, escalating in cohorts of three patients each according to a standard dose-escalation design. After the first patient in each dose group is treated, there is a 28-day observation period to monitor for dose-limiting toxicities before enrolling additional patients or moving to a higher dose level. The treatment involves one needle injection per tumor, delivered intra-tumorally. Participants will be actively involved for up to two months, attending seven clinic visits and about four lab visits for evaluations. These visits include standard care procedures and study-specific tests such as blood draws, oral swabs, urinalysis, and tissue biopsies for tumor response and genomic analysis. The study team will monitor side effects closely, including pain, rash, fever, and fatigue, with particular attention to rare risks like rash transmission. Data and tissue samples may be used for future research.
CONDITIONS
Brief Title
Intra-tumoral (IT) Injection of vvDD-hIL2-2-RG-1 for Metastatic Gastrointestinal and Peritoneal Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males or females aged 18 to under 70 years at consent
- Histologically confirmed metastatic gastrointestinal tumors with molecular markers for MSI and KRAS
- For microsatellite stable tumors, failure or ineligibility for standard 1st and 2nd line chemotherapy
- For microsatellite instability-high tumors, failure or ineligibility for systemic immunotherapy
- Karnofsky Performance Status greater than 70
- Anticipated survival of at least 12 weeks
- Written informed consent obtained prior to study procedures
- Adequate bone marrow function with specified blood cell counts
- Adequate renal function with serum creatinine ≤ 2 times upper limit of normal
- Adequate liver function with serum bilirubin less than 1.5 times upper limit of normal
- Acceptable coagulation status and ability to suspend anticoagulant therapy for biopsies and injection
- Negative pregnancy test for women of childbearing potential
- Use of contraception and barrier methods from screening through 6 weeks post-treatment
- Willingness to comply with all study procedures and follow-up
- Measurable disease per RECIST 1.1 criteria
- At least one tumor ≥ 1 cm suitable for safe intra-tumoral injection
You will not qualify if you...
- Pregnant or nursing an infant
- Use of systemic corticosteroids or immunosuppressive medications within 2 weeks before treatment
- Significant immunodeficiency in participant or household contacts
- Active infection or uncontrolled medical conditions considered high risk by investigators
- Active eczema, psoriasis, or other inflammatory skin conditions
- Unstable cardiac disease or recent serious heart conditions within 6 months
- Receipt of radiation, chemotherapy, or immunosuppressive therapy within 2 to 4 weeks before treatment
- Severe reaction to previous smallpox vaccination
- Medical conditions posing prohibitive risk or inability to safely complete biopsies
- Household contacts who are children under 5 years, have active skin conditions, or immunodeficiency unless alternate living arrangements are made
- Live virus vaccination within 60 days prior to treatment
- Inability or unwillingness to give informed consent or comply with follow-up requirements
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single dose with 28 days observation
Participants receive a single intra-tumoral injection of the investigational agent vvDD-hIL-2-RG-1 at one of three dose levels.
1 injection visit and multiple observation visits over 28 days
Duration - Up to 28 days
Participants are observed for safety and immune response for up to 28 days after treatment.
Multiple visits for safety and immune monitoring over 28 days
Trial Site Locations
Total: 1 location
1
AHN West Penn Hospital
Pittsburgh, Pennsylvania, United States, 15224
Actively Recruiting
Research Team
P
Patrick Wagner, MD
A
AHN Clinical Trial Contact
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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