A Study of More Frequent Dosing of VCN-01 Combined With Standard Chemotherapy in Patients With Ne… (NCT07701486) | Clinical Trial Compass
RecruitingPhase 1/2
A Study of More Frequent Dosing of VCN-01 Combined With Standard Chemotherapy in Patients With Newly Diagnosed Metastatic Pancreatic Cancer
Spain6 participantsStarted 2026-08-03
Plain-language summary
The goal of this clinical trial is to learn if the new administration regimen of VCN-01, given together with the standard chemotherapy drugs gemcitabine and nab-paclitaxel (GnP), is safe and well tolerated. The behaviour of VCN-01 in the organism will be assessed, together with the possible benefits of this administration regimen. This study includes adults with newly diagnosed pancreatic ductal adenocarcinoma (PDAC) that has spread to other parts of the body (stage IV) and who have not received prior treatment for pancreatic cancer.
Participants will receive three planned doses of VCN-01, given once every 56 days. Each dose of VCN-01 is followed one week later by two cycles of standard chemotherapy with gemcitabine and nab-paclitaxel. Participants will be monitored throughout the study for safety and side effects.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Written informed consent obtained prior to initiating any trial-specific procedures or assessments.
* Male or female patients aged 18 years or over.
* Patients with histologically or cytologically confirmed pancreatic adenocarcinoma that is metastatic (stage IV) at diagnosis and who have not received any treatment for their pancreatic cancer.
* Patients must be able to receive their first dose of VCN-01 ≤6 weeks after their metastatic pancreatic cancer diagnosis.
* Patients must have at least one measurable tumor lesion that can be imaged for assessments according to RECIST 1.1.
* ECOG performance status of 0 or 1 at enrollment.
* Must be willing to comply with the trial intervention, including prophylactic medications, and procedures.
* Adequate baseline organ function (hematologic, liver, renal) within the 7 days prior to enrollment:
Hematology:
* Leukocytes ≥3.0x103 mcL
* Absolute neutrophil count ≥1.5x10⁹/L
* Hemoglobin ≥9 g/dL
* Platelets ≥100x10⁹/L
Coagulation:
* 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 (\<5xULN is acceptable if liver metastases are present)
Renal:
* Serum creatinine ≤1.5xULN; or,
* If serum creatinine \>1.5xULN, an estimated creatinine clearance \>50 mL/min using the Cockcroft and Gault formula
Nutritional:
• Serum Albumin ≥30 g/L
\- Adequate left ventricular ejection fra…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of Treatment-Emergent Adverse Events
Timeframe: From enrolment up to 30-days from the last dose of study intervention
2
Pharmacokinetics (PK) of VCN-01
Timeframe: From enrollment up to 30 days from the last dose of study intervention