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Study to evaluate the impact of VCN-01 on the overall survival of patients with advanced pancreatic cancer treated with standard therapy.
EU CTIS ID: 2024-511290-30-00
What this study is testing
To evaluate the time from randomization until death in both arms (OS). To evaluate the safety and tolerability of VCN-01, IV administered at Week 1 and Week 14 in Arm II.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Written informed consent obtained prior to any study-specific procedures or assessments.
- Male/female patients aged 18 years or over.
- Patients with histologically or cytologically confirmed, first line metastatic pancreatic adenocarcinoma stage IV de novo, who never received previous systemic treatment for their pancreatic cancer for which the established therapy is nab-paclitaxel/gemcitabine (clinical SoC). All patients must have at least one measurable tumor lesion that can be imaged for assessments determined by RECIST 1.1.
- Patients willing to comply with the study treatment.
- Patients with a minimum life expectancy of 5 months.
- ECOG performance status of 0 or 1
You likely can't join if
- Patients not willing to complete the study procedures for geographic, psychiatric, or social reasons.
- Patients with Li Fraumeni syndrome or with previously known retinoblastoma protein pathway germline deficiency.
- A female patient, who is pregnant or lactating.
- Patients receiving full-dose anticoagulant therapy or in whom these therapies cannot be withdrawn 2 days prior and 2 days after VCN-01 administration. Patients with uncontrolled coagulopathy should be excluded.
- Untreated brain metastases and/or leptomeningeal carcinomatosis with progressive symptoms despite corticosteroid coverage. Patients with brain metastases with stable symptoms can be included.
- Any other condition, disease, metabolic dysfunction (e.g., uncontrolled diabetes mellitus), active or uncontrolled infection/inflammation, physical examination finding, mental state or clinical laboratory finding that would contraindicate participation in the clinical study due to safety concerns or compliance with clinical study procedures.
See the full eligibility criteria
Who can join
- Written informed consent obtained prior to any study-specific procedures or assessments.
- Male/female patients aged 18 years or over.
- Patients with histologically or cytologically confirmed, first line metastatic pancreatic adenocarcinoma stage IV de novo, who never received previous systemic treatment for their pancreatic cancer for which the established therapy is nab-paclitaxel/gemcitabine (clinical SoC). All patients must have at least one measurable tumor lesion that can be imaged for assessments determined by RECIST 1.1.
- Patients willing to comply with the study treatment.
- Patients with a minimum life expectancy of 5 months.
- ECOG performance status of 0 or 1
- Use of a reliable method of contraception in fertile men and women. Female patients of childbearing potential (i.e., female patients who are not postmenopausal or surgically sterile) must agree to use effective contraception. Male patients must agree to use effective contraception or be surgically sterile. All male patients must use a male condom.
- Adequate baseline organ function (hematologic, liver, renal and nutritional) verified by laboratory analyses performed within 72 hours prior to dosing*: Hematology: Absolute neutrophil count #1.5x109 /L, Hemoglobin #9 g/dL, Platelets #100x109/L, Coagulation (*except in patients on anticoagulants), Prothrombin time or international normalized ratio #1x upper limit of normal (ULN), Activated partial thromboplastin time #1.2xULN Hepatic:Total bilirubin #1.5xULN, ALT and AST #2.5xULN (if there are no liver metastases), ALT and AST <5xULN, and bilirubin <1.5xULN (if there are liver metastases) Renal: Serum creatinine #1.5xULN, and if >1.5xULN: Estimated creatinine, clearance >50 mL/min using Cockcroft and Gault formula Nutritional: Serum Albumin #30 g/L
What rules you out
- Patients not willing to complete the study procedures for geographic, psychiatric, or social reasons.
- Patients with Li Fraumeni syndrome or with previously known retinoblastoma protein pathway germline deficiency.
- A female patient, who is pregnant or lactating.
- Patients receiving full-dose anticoagulant therapy or in whom these therapies cannot be withdrawn 2 days prior and 2 days after VCN-01 administration. Patients with uncontrolled coagulopathy should be excluded.
- Untreated brain metastases and/or leptomeningeal carcinomatosis with progressive symptoms despite corticosteroid coverage. Patients with brain metastases with stable symptoms can be included.
- Any other condition, disease, metabolic dysfunction (e.g., uncontrolled diabetes mellitus), active or uncontrolled infection/inflammation, physical examination finding, mental state or clinical laboratory finding that would contraindicate participation in the clinical study due to safety concerns or compliance with clinical study procedures.
- Patients with previous pneumonitis or interstitial lung disease.
- Patients with pre-existing sensory neuropathy >G1.
- Patients with risk factors for bowel perforation.
- Patients with QT interval corrected by Fridericia (QTcF) assessment >450 ms for men or >470 ms for women and left ventricular ejection fraction (LVEF) evaluation less than 50% measured by ECHO or multigated acquisition scan.
- Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.
- Active infection or other serious illness or autoimmune disease at the moment of randomization. Active infection includes tuberculosis (TB; clinical evaluation that includes clinical history, physical examination and radiographic findings, and TB testing in line with local practice), hepatitis B (HBV; positive HBV surface antigen [HBsAg] result), hepatitis C (HCV; positive HCV Ribonucleic acid [RNA]), or human immunodeficiency virus (positive HIV 1/2 antibodies). HBV carriers (patients positive or HBsAg) or those patients requiring antiviral therapy treatment for HBV virus or HCV are not eligible to participate. However, the following patients are eligible to participate in the study: - Patients with past or resolved TB are eligible; - Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [HBcAb] and absence of HBsAg) are eligible. Blood HBV DNA must be obtained and must be negative in these patients prior to treatment; - Patients positive for HCV antibody are eligible only if polymerase chain reaction is negative for HCV RNA.
- Subjects, for whom first line treatment options other than the combination Gemcitabine/Nab-Paclitaxel are recommended by the investigator.
- Treatment with live attenuated vaccines in the last 3 weeks and with the adenovirus type-5 (Ad5)-based COVID-vaccine in the last 12 weeks before the administration of study treatment.
- Known chronic liver disease (liver cirrhosis, chronic hepatitis). If there is a suspect of hepatic fibrosis, a fibroscan must be performed; patients with a value #9.5 kPa will be excluded. Note: Transient elastography (Fibroscan) is a non-invasive method for the assessment of hepatic fibrosis.
- Treatment with another investigational agent within five of that treatment’s half-lives prior to infusion of study treatment.
- Viral syndrome diagnosed during the 2 weeks before start of study treatment administration.
- Chronic immunosuppressive and/or disease modifying therapy, except inhaled corticosteroids, and oral or IV corticosteroids with a dose lower than 10 mg prednisone or equivalent/day (exception: dexamethasone 1 mg/day as maximum).
- Concurrent malignant hematologic or solid disease. Patients with a prior history of cancer can be allowed if complete remission for at least 3 years.
- Patients in close contact (e.g., living in same house) with immunosuppressed patients (i.e., patients with chronic immunosuppressive therapy including high dose of corticosteroids, patients with acquired immunodeficiency syndrome (AIDS), and other chronic immune system diseases).
The study team makes the final eligibility decision.
Where it's taking place
- 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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include 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 EU CTIS; the study team decides eligibility.