Clinical trial · Interventional
A Phase I Dose Escalation Study of Intratumoral VCN-01 Injections With Gemcitabine and Abraxane® in Patients With Advanced Pancreatic Cancer
A Phase I, Multicenter, Open-label, Dose Escalation Study of Intratumoral Injections of VCN-01 Oncolytic Adenovirus With Intravenous Gemcitabine and Abraxane® in Advanced Pancreatic Cancer
NCT02045589CI-TRIAL-00035089completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to determine the safety and tolerability of three intratumoral injections of VCN-01 combined with Abraxane®/gemcitabine, and to determine the recommended phase II dose of VCN-01 combined with Abraxane®/gemcitabine.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Pancreatic Adenocarcinoma | Pancreatic Adenocarcinoma | CURATED_BROADER | 0.78 |
| Pancreatic Adenocarcinoma | Pancreatic Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Abraxane® | Drug | Paclitaxel | ALIAS |
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| VCN-01 | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Dose Escalation, Combination
- description
- Three intratumoral administrations of VCN-01 oncolytic adenovirus every 28 days in combination with Abraxane® and Gemcitabine.
- interventionNames
- Genetic: VCN-01
- Drug: Gemcitabine
- Drug: Abraxane®
Primary outcomes (2)
- measure
- Safety and Tolerability by means of Adverse Events (AEs) and laboratory data
- timeFrame
- At least 6 months
- measure
- Recommended Phase 2 Dose (RP2D) of VCN-01 in combination with Gemcitabine and Abraxane® by determination of highest feasible dose (MFD) and any Dose Limiting Toxicities
- timeFrame
- At least 6 months
Secondary outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Male/Female patients aged 18 years or over * Patients must provide written informed consent * Life expectancy above 3 months * Patients willing to comply with treatment follow-up, and to accept a biopsy at day 29 after initiation of the treatment * Patients with histologically confirmed diagnosis of unresectable pancreatic adenocarcinoma with symptoms related to the primary tumor. Abraxane® plus Gemcitabine should be the appropriate standard of care to be administered. * ECOG Performance status 0 or 1 * Adequate baseline organ function (hematologic, liver, renal and nutritional) * Use a reliable method of contraception in fertile men and women Exclusion Criteria: * Active infection or other serious illness or autoimmune disease * Treatment with live attenuated vaccines in the last three weeks * Known chronic liver disease (liver cirrhosis, chronic hepatitis) * Treatment with another investigational agent within its five half-lives prior to VCN-01 infusion * Viral syndrome diagnosed during the two weeks before inclusion * Chronic immunosuppressive therapy * Known concurrent malignant hematologic or solid disease * Pregnancy or lactation. Patients must agree to use effective contraception or be surgically sterile. * Patients receiving full-dose anticoagulant / antiplatelet therapy * Patients with Li Fraumeni syndrome or with previous known retinoblastoma protein pathway germinal deficiency
References
Publications (1)
- DERIVEDBazan-Peregrino M, Garcia-Carbonero R, Laquente B, Alvarez R, Mato-Berciano A, Gimenez-Alejandre M, Morgado S, Rodriguez-Garcia A, Maliandi MV, Riesco MC, Moreno R, Ginesta MM, Perez-Carreras M, Gornals JB, Prados S, Perea S, Capella G, Alemany R, Salazar R, Blasi E, Blasco C, Cascallo M, Hidalgo M. VCN-01 disrupts pancreatic cancer stroma and exerts antitumor effects. J Immunother Cancer. 2021 Nov;9(11):e003254. doi: 10.1136/jitc-2021-003254. PMID 35149591