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New treatment option for Gastric Neoplasms
Official title Intra-tumoral (IT) Injection of vvDD-hIL2-2-RG-1 for Metastatic Gastrointestinal and Peritoneal Tumors
ClinicalTrials.gov ID: NCT07001592
What this study is testing
What is vvDD-hIL-2-RG-1?
vvDD-hIL-2-RG-1 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for gastric neoplasms.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 69
You may be able to join if
- Males or females age, 18 to \< 70 years at the time of consent
- Histologically confirmed metastases from gastrointestinal tumors with molecular determinants for MSI and KRAS.
- For microsatellite stable (MSS) tumors, people must have failed (or be ineligible for) standard 1st and 2nd line chemotherapy. For microsatellite...
- Karnofsky Performance Status (KPS) of \> 70
- Anticipated survival of at least 12 weeks.
You likely can't join if
- Pregnant or nursing an infant.
- Systemic corticosteroid or other immunosuppressive medication use within 2 weeks of the study treatment.
- Significant immunodeficiency (e.g. due to underlying illness and/or medication) in subject or household contacts (must be able to avoid household...
- Clinically significant active infection or uncontrolled medical condition (e.g., pulmonary, neurological, cardiovascular, gastrointestinal...
- Active eczema or psoriasis or other inflammatory skin conditions
- Unstable cardiac disease which includes but is not limited to any of the following within 6 months prior to study entry: myocardial infarction (MI)...
See the full eligibility criteria
- Males or females age, 18 to \< 70 years at the time of consent
- Histologically confirmed metastases from gastrointestinal tumors with molecular determinants for MSI and KRAS.
- For microsatellite stable (MSS) tumors, people must have failed (or be ineligible for) standard 1st and 2nd line chemotherapy. For microsatellite instability-high (MSI-H) tumors, people must also have failed (or be...
- Karnofsky Performance Status (KPS) of \> 70
- Anticipated survival of at least 12 weeks.
- 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...
- Adequate bone marrow function: WBC \> 2,000 and \ 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
- Acceptable coagulation status: INR \< ULN +15%. All patients must be able to suspend anticoagulant therapy for study specific biopsies and intra-tumoral injection.
- Women of childbearing potential (defined as all women physiologically capable of becoming pregnant) must have negative serum or urine pregnancy test.
- 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...
- people must be willing to comply with all study procedures, requirements, adhere to post-treatment care instructions and follow-up examinations.
- Have measurable disease based on RECIST 1.1 criteria.
- Have at least one tumor at least 1 cm in diameter amenable to safe intra-tumoral injection.
- Pregnant or nursing an infant.
- Systemic corticosteroid or other immunosuppressive medication use within 2 weeks of the study treatment.
- 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).
- Clinically significant active infection or uncontrolled medical condition (e.g., pulmonary, neurological, cardiovascular, gastrointestinal, genitourinary) considered high risk for investigational new drug treatment, per...
- Active eczema or psoriasis or other inflammatory skin conditions
- 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...
- New York Heart Association functional class III-IV heart failure on active treatment
- Pulse oximetry of \< 90% in room air at rest
- people 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.
- Experienced a severe systemic reaction or side-effect as a result of a previous smallpox vaccination.
- people 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...
- people 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...
- Vaccination with a live virus in the previous 60 days prior to Day 0.
- Inability or unwillingness to give informed consent.
- Is unable or unwilling to comply with protocol follow-up requirements. -
The study team makes the final eligibility decision.
Where it's taking place
- Pittsburgh, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 69 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Pittsburgh, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.