OncoMatch/Clinical Trials/NCT07001592
Intra-tumoral (IT) Injection of vvDD-hIL2-2-RG-1 for Metastatic Gastrointestinal and Peritoneal Tumors
Is NCT07001592 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies vvDD-hIL-2-RG-1 for gastric neoplasms.
Treatment: vvDD-hIL-2-RG-1 — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Esophageal Carcinoma
Hepatocellular Carcinoma
Gastric Cancer
Ovarian Cancer
Biomarker criteria
Required: KRAS any tested
molecular determinants for MSI and KRAS
Allowed: MMR microsatellite stable
For microsatellite stable (MSS) tumors, subjects must have failed (or be ineligible for) standard 1st and 2nd line chemotherapy.
Allowed: MMR microsatellite instability-high
For microsatellite instability-high (MSI-H) tumors, subjects must also have failed (or be ineligible for) systemic immunotherapy.
Disease stage
Metastatic disease required
Prior therapy
Must have received: chemotherapy — standard 1st and 2nd line
For microsatellite stable (MSS) tumors, subjects must have failed (or be ineligible for) standard 1st and 2nd line chemotherapy.
Must have received: immunotherapy — systemic
For microsatellite instability-high (MSI-H) tumors, subjects must also have failed (or be ineligible for) systemic immunotherapy.
Cannot have received: radiation therapy
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.
Cannot have received: chemotherapy
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.
Cannot have received: immunosuppressive therapy
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.
Lab requirements
Blood counts
WBC > 2,000 and <50,000 cells/mm3, ANC > 1,000 cells/mm3, hemoglobin >8 g/dL, and platelet count >100,000 cells/mm3
Kidney function
serum creatinine level ≤ 2xULN
Liver function
Serum bilirubin < 1.5 x ULN
Adequate bone marrow function: WBC > 2,000 and <50,000 cells/mm3, ANC > 1,000 cells/mm3, hemoglobin >8 g/dL, and platelet count >100,000 cells/mm3. Adequate renal function: serum creatinine level ≤ 2xULN. Adequate liver function: Serum bilirubin < 1.5 x ULN
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- AHN West Penn Hospital · Pittsburgh, Pennsylvania
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