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

NCT07701486 | Recruiting Phase 1

• 1 other identifier: P-VCNA-004
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pancreas Cancer, Metastatic; Pancreas Cancer, Stage IV; Ductal Adenocarcinoma of the Pancreas

Keywords

VCN-01; mPDAC; gemcitabine; nab-paclitaxel

Outcome Measures

Primary Outcomes (2)

• Incidence of Treatment-Emergent Adverse Events

  Frequency and proportion of participants experiencing AEs/SAEs; descriptive statistics for laboratory values.

  From enrolment up to 30-days from the last dose of study intervention

• Pharmacokinetics (PK) of VCN-01

  VCN-01 concentration in blood at predefined time points.

  From enrollment up to 30 days from the last dose of study intervention

Study Arms (1)

High dose

EXPERIMENTAL

The initial dosing regimen for this study comprises three "macrocycles", each of which comprises one dose of VCN-01 followed one week later by 2 cycles of GnP according to standard of care

Biological: VCN-01 oncolytic adenovirus (zabilugene almadenorepvec); Drug: Nab-paclitaxel + Gemcitabine

Interventions

VCN-01 oncolytic adenovirus (zabilugene almadenorepvec) BIOLOGICAL

The initial dosing regimen for this study comprises up to three "macrocycles", each of which comprises one dose of VCN-01 followed one week later by 2 cycles of GnP according to standard of care (SoC)

High dose

Nab-paclitaxel + Gemcitabine DRUG

IV nab-paclitaxel (starting dose 125 mg/m²) followed by IV gemcitabine (starting dose 1,000 mg/m²) according to SoC clinical practice (GnP SoC). Dose modifications and interruptions permitted per prescribing information/SmPC.

High dose

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Unwillingness to complete the trial procedures for geographic, psychiatric, or social reasons.
• 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.
• Patients who, in the opinion of the investigator, have symptoms or signs suggesting clinically unacceptable deterioration during the Screening Period.
• Active infection or other serious illness or autoimmune disease at the moment of enrollment. Active infection includes:
• Tuberculosis (TB; clinical evaluation that includes clinical history, physical examination and radiographic findings, and TB testing in line with local practice.
• Patients with past or resolved TB are eligible to participate.
• Hepatitis B Virus (HBV; positive HBV surface antigen \[HBsAg\] result).
• HBV carriers (patients positive for HBsAg without an active infection) are not eligible to participate;
• Patients requiring antiviral medicines for HBV prophylaxis or treatment are not eligible to participate;
• Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody \[HBcAb\] and absence of HBsAg) are eligible to participate provided that blood HBV DNA is negative at enrollment.
• Hepatitis C Virus (HCV; positive HCV Ribonucleic acid \[RNA\]).
• Patients requiring antiviral medicines for HCV prophylaxis or treatment are not eligible to participate;
• Patients positive for HCV antibody are eligible to participate (only if polymerase chain reaction is negative for HCV RNA).

Sponsors & Collaborators

• Theriva Biologics SL: lead

Study Sites (1)

Hospital 12 de Octubre

Madrid, Madrid, 28041, Spain

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms; Neoplasm Metastasis

Interventions

130-nm albumin-bound paclitaxel; Gemcitabine

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Central Study Contacts

Manel Cascalló CEO, PhD

CONTACT

+93936899365; mcascallo@therivabio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Three planned doses of VCN-01 administered every 56 days, combined with GnP treatment in the participant Population

Study Record Dates

• First Submitted: July 8, 2026
• First Posted: July 14, 2026
• Study Start (Estimated): August 3, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: July 27, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)