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

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Study ID
NCT07001592
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 69 Years
Healthy Volunteers
Not accepted

Interventions

  • vvDD-hIL-2-RG-1 — BIOLOGICAL
    A single dose of the investigational agent will be injected intratumorally at one of the following three dose levels. Level 1: 3 x 108 p.f.u. Level 2: 1 x 109 p.f.u. Level 3: 3 x 109 p.f.u. p.f.u = Plaque-forming unit(s) Dose will be escalated in cohorts of 3, according to a standard 3+3 design.

Study Details

This research study aims to evaluate the safety and determine the optimal dose of a new experimental drug, vvDD-hIL2 (vaccinia virus double-deleted human interleukin 2), in patients with advanced abdominal cancer. The study will involve three dose levels, with three to six patients enrolled at each level. vvDD-hIL2 is a genetically modified vaccinia virus, derived from the virus previously used for smallpox vaccination. The modification is intended to target and destroy tumors while minimizing harm to healthy tissues by stimulating the body's immune response. Participants will receive an injection of vvDD-hIL2 directly into their abdominal tumors at AHN West Penn. The study team will monitor for side effects and assess tumor response to the treatment. Active participation will last up to two months, involving seven clinic visits and approximately four lab visits at AHN West Penn Hospital. Visits will include standard of care procedures as well as study-specific tests and exams. Most visits will last one to two hours, with some extending to two to three hours. The drug administration day will require a twelve-hour visit. Effectiveness and side effects will be evaluated through blood draws, oral swabs, urinalysis and tissue biopsies. Tissue samples will be used for genomic analysis and stored for potential future research. Data collected may also be used for future research purposes. Previous human trials of vvDD-hIL2 have reported side effects such as pain, rash or inflammation at the injection site, low-grade fevers, flu-like symptoms, and fatigue. There is a rare risk of rash transmission to close contacts with skin openings, and information on limiting contact and managing rash development will be provided.

Key Dates

Start date
May 6, 2025
Status verified
May 2025
Primary completion
Apr 30, 2028
Completion
May 31, 2028

Study Design

Enrollment
18 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: vvDD-hIL-2-RG-1
    vvDD-hIL-2-RG-1 administered via intra-tumoral (IT) injection

Primary Outcome Measure

Incidence of Treatment-Emergent Adverse Events (Safety) of vvDD-hIL-2-RG-1 [ Time Frame: maximum 28 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
AHN West Penn HospitalPittsburghPennsylvania15224
Patrick Wagner, MD
[email protected]
412-359-3731
AHN Clinical Trial Contact
[email protected]
412-359-3731
Patrick Wagner, MD (PRINCIPAL_INVESTIGATOR)
David Bartlett, MD (SUB_INVESTIGATOR)
Albert Donnenberg, PhD (SUB_INVESTIGATOR)
Casey Allen, MD (SUB_INVESTIGATOR)
Yazan Samhouri, MD (SUB_INVESTIGATOR)
Nathan Bahary, MD (SUB_INVESTIGATOR)

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By specialty
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By research site
AHN West Penn Hospital· Pittsburgh, PA

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