Study to evaluate the impact of VCN-01 on the overall survival of patients with advanced pancreatic cancer treated with standard therapy.
- Conditions
- Metastatic Pancreatic CancerMedDRA version: 21.1Level: LLTClassification code 10033605Term: Pancreatic cancer metastaticSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2022-000897-24-DE
- Lead Sponsor
- Theriva Biologics, S.L.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 92
1. Written informed consent obtained prior to any study-specific procedures or assessments.
2. Male/female patients aged 18 years or over.
3. 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 (see APPENDIX 4).
4. Patients willing to comply with the study treatment.
5. Patients with a minimum life expectancy of 5 months.
6. ECOG performance status of 0 or 1.
7. 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.
8. Adequate baseline organ function (hematologic, liver, renal and nutritional) within 1 week of randomization:
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
Note: If laboratory or imaging procedures were performed for alternate reasons prior to signing consent, these can be used for screening purposes with consent of the patient.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 45
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 45
1. Patients not willing to complete the study procedures for geographic, psychiatric, or social reasons.
2. 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 RNA), or human immunodeficiency virus (positive HIV 1/2 antibodies). HBV carriers (patients positive for HBsAg) or those patients requiring antiviral therapy treatment for BHBV virus or CHCV 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. HBV DNA must be obtained in these patients prior to treatment.
- Patients positive for HCV antibody are eligible only if polymerase chain reaction is negative for HCV RNA.
3. 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.
4. 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.
5. Treatment with another investigational agent within five of that treatment’s half-lives prior to infusion of study treatment.
6. Viral syndrome diagnosed during the 2 weeks before start of study treatment administration.
7. 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).
8. Concurrent malignant hematologic or solid disease. Patients with a prior history of cancer can be allowed if complete remission for at least 3 years.
9. 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).
10. Patients with Li Fraumeni syndrome or with previously known retinoblastoma protein pathway germline deficiency.
11. A female patient, who is pregnant or lactating.
12. 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.
13. Untreated brain metastases and/or leptomeningeal carcinomatosis with progressive symptoms despite corticosteroid coverage. Patients with brain metastases with stable symptoms, which are not clinically relevant, can be included.
14. 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objectives are:<br>• To evaluate the time from randomization until death in both arms (OS).<br>• To evaluate the safety and tolerability of VCN-01, IV administered at Week 1 and Week 14 in Arm II.;Secondary Objective: The secondary objectives are:<br>• To evaluate the time to progression (TTP) or PFS.<br>• To determine the ORR.<br>• To determine the disease control rate (DCR) (stable disease [SD] + PR + complete response [CR]).<br>• To determine the landmark 1-year survival and PFS at the 1-year landmark.<br>• To evaluate the duration of response (DoR).<br>• To assess changes in tumor marker Ca 19.9 measured every 4 weeks while on study.;Primary end point(s): • OS<br>• Safety and tolerability<br>;Timepoint(s) of evaluation of this end point: Along the study<br><br>
- Secondary Outcome Measures
Name Time Method Secondary end point(s): • PFS or TTP<br>• ORR<br>• DCR (SD + PR + CR)<br>• Landmark 1-year survival and PFS at the 1-year landmark<br>• DoR<br>• Changes in tumor marker Ca 19.9<br>;Timepoint(s) of evaluation of this end point: Along the study<br><br>