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OncoMatch/Clinical Trials/NCT07701486

A Study of More Frequent Dosing of VCN-01 Combined With Standard Chemotherapy in Patients With Newly Diagnosed Metastatic Pancreatic Cancer

Is NCT07701486 recruiting? Yes, currently enrolling (Sep 2026). This Phase 1/2 trial studies multiple treatments including VCN-01 oncolytic adenovirus (zabilugene almadenorepvec) and Nab-paclitaxel + Gemcitabine for pancreas cancer, metastatic.

Phase 1/2RecruitingTheriva Biologics SLNCT07701486Data as of Sep 2026Location: Spain

Treatment: VCN-01 oncolytic adenovirus (zabilugene almadenorepvec) · Nab-paclitaxel + GemcitabineThe 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.

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Extracted eligibility criteria

Treatments studied

Chemotherapy

Nab-paclitaxel + Gemcitabine

Other

VCN-01 oncolytic adenovirus (zabilugene almadenorepvec)

Cancer type

Pancreatic Cancer

Disease stage

Required: Stage IV

Metastatic disease required

Performance status

ECOG 0–1(Restricted strenuous activity)

ECOG performance status of 0 or 1 at enrollment

Prior therapy

Max 0 prior lines

Cannot have received: surgery for metastatic pancreatic cancer

Patient has previously received treatment for their metastatic pancreatic cancer with surgery, radiotherapy, chemotherapy or investigational therapy; except that: Palliative radiotherapy for pain is permitted; Placement of a biliary stent/tube is permitted.

Cannot have received: radiotherapy for metastatic pancreatic cancer

Exception: palliative radiotherapy for pain is permitted

Patient has previously received treatment for their metastatic pancreatic cancer with surgery, radiotherapy, chemotherapy or investigational therapy; except that: Palliative radiotherapy for pain is permitted; Placement of a biliary stent/tube is permitted.

Cannot have received: chemotherapy for metastatic pancreatic cancer

Patient has previously received treatment for their metastatic pancreatic cancer with surgery, radiotherapy, chemotherapy or investigational therapy; except that: Palliative radiotherapy for pain is permitted; Placement of a biliary stent/tube is permitted.

Cannot have received: investigational therapy for metastatic pancreatic cancer

Patient has previously received treatment for their metastatic pancreatic cancer with surgery, radiotherapy, chemotherapy or investigational therapy; except that: Palliative radiotherapy for pain is permitted; Placement of a biliary stent/tube is permitted.

Lab requirements

Blood counts

Leukocytes ≥3.0x10^3/mcL; ANC ≥1.5x10^9/L; Hemoglobin ≥9 g/dL; Platelets ≥100x10^9/L

Kidney function

Serum creatinine ≤1.5xULN; or, if serum creatinine >1.5xULN, estimated creatinine clearance >50 mL/min (Cockcroft and Gault)

Liver function

Total bilirubin ≤1.5xULN; ALT and AST ≤2.5xULN (<5xULN if liver metastases present)

Cardiac function

LVEF ≥50% by ECHO or MUGA; QTcF ≤450 ms (men) or ≤470 ms (women)

Adequate baseline organ function (hematologic, liver, renal) within the 7 days prior to enrollment: ... Adequate left ventricular ejection fraction (LVEF) ≥ 50% measured by ECHO or MUGA and QT interval corrected by Fridericia (QTcF) assessment ≤ 450 ms for men or ≤ 470 ms for women.

Structured fields extracted by AI. May contain errors — verify against the official protocol.

Frequently asked questions

Is NCT07701486 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior surgery for metastatic pancreatic cancer, radiotherapy for metastatic pancreatic cancer, chemotherapy for metastatic pancreatic cancer disqualifies patients from enrollment.

What disease stage is eligible?

Stage IV is required (metastatic disease required).

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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