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

Launched by ALLEGHENY SINGER RESEARCH INSTITUTE (ALSO KNOWN AS ALLEGHENY HEALTH NETWORK RESEARCH INSTITUTE) · Jun 2, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new experimental treatment called vvDD-hIL2, which is being tested for patients with advanced abdominal cancers, such as gastric and liver cancer. The goal of the trial is to find out how safe this treatment is and what the best dose might be. The treatment involves injecting the drug directly into the tumors to help the body’s immune system attack and destroy them while sparing healthy tissues. The study will include three different dose levels, with three to six patients participating at each level.

To be eligible for this trial, participants should be between 18 and 70 years old and have certain types of advanced gastrointestinal tumors that have not responded to standard treatments. They should also be generally healthy and able to undergo the required tests and injections. During the trial, participants will visit the clinic several times over two months for the treatment and check-ups, which will include blood tests and other assessments to monitor for side effects and see how well the treatment is working. Some common side effects from previous studies include pain or rash at the injection site, low-grade fevers, and fatigue. It's important for participants to follow specific guidelines to manage any potential risks, especially regarding contact with others during the treatment period.

Gender

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Eligibility criteria

• Inclusion Criteria:
• • 1. Males or females age, 18 to \< 70 years at the time of consent
• • 2. Histologically confirmed metastases from gastrointestinal tumors with molecular determinants for MSI and KRAS.
• • 3. For microsatellite stable (MSS) tumors, subjects must have failed (or be ineligible for) standard 1st and 2nd line chemotherapy. For microsatellite instability-high (MSI-H) tumors, subjects must also have failed (or be ineligible for) systemic immunotherapy.
• • 4. Karnofsky Performance Status (KPS) of \> 70
• • 5. Anticipated survival of at least 12 weeks.
• • 6. Written informed consent in accordance with national, local, and institutional guidelines obtained prior to any study procedures (subject or subject's legally authorized representative (LAR) must have the ability to understand and willingness to sign a written informed consent).
• • 7. 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.
• • 8. Adequate renal function: serum creatinine level ≤ 2xULN
• • 9. Adequate liver function: Serum bilirubin \< 1.5 x ULN
• • 10. Acceptable coagulation status: INR \< ULN +15%. All patients must be able to suspend anticoagulant therapy for study specific biopsies and intra-tumoral injection.
• • 11. Women of childbearing potential (defined as all women physiologically capable of becoming pregnant) must have negative serum or urine pregnancy test.
• • 12. If sexually active, to prevent pregnancy and to prevent the spread of virus, subject must use an acceptable method of contraception as well as barrier contraception from screening through 6 weeks following study treatment with vvDD-hIL-2-RG-1.
• • 13. Subjects must be willing to comply with all study procedures, requirements, adhere to post-treatment care instructions and follow-up examinations.
• • 14. Have measurable disease based on RECIST 1.1 criteria.
• • 15. Have at least one tumor at least 1 cm in diameter amenable to safe intra-tumoral injection.
• Exclusion Criteria:
• • 1. Pregnant or nursing an infant.
• • 2. Systemic corticosteroid or other immunosuppressive medication use within 2 weeks of the study treatment.
• • 3. Significant immunodeficiency (e.g. due to underlying illness and/or medication) in subject or household contacts (must be able to avoid household contact with immunodeficient person for 3 weeks).
• • 4. Clinically significant active infection or uncontrolled medical condition (e.g., pulmonary, neurological, cardiovascular, gastrointestinal, genitourinary) considered high risk for investigational new drug treatment, per investigator discretion.
• • 5. Active eczema or psoriasis or other inflammatory skin conditions
• • 6. Unstable cardiac disease which includes but is not limited to any of the following within 6 months prior to study entry: myocardial infarction (MI), unstable angina, congestive heart failure, myocarditis, ventricular arrhythmias diagnosed and requiring medication.
• • 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. -