Evidence map›Paper›PMID 35338084›Full record

ArticleJournal for immunotherapy of cancer2022

Phase I, multicenter, open-label study of intravenous VCN-01 oncolytic adenovirus with or without nab-paclitaxel plus gemcitabine in patients with advanced solid tumors.

Rocio Garcia-Carbonero, Miriam Bazan-Peregrino, Marta Gil-Martín, Rafael Álvarez, Teresa Macarulla, Maria C Riesco-Martinez, Helena Verdaguer, Carmen Guillén-Ponce, Martí Farrera-Sal, Rafael Moreno and 14 more

Registry-linked trialOpen access · goldAbstract readMulticenter Study
In one paragraph

Article in Journal for immunotherapy of cancer, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02045602 (A Phase I, Multicenter, Open-label, Dose Escalation Study of Intravenous Administration of VCN-01 Oncolytic Adenovirus With or Without Gemcitabine and Abraxane® in Patients With Advanced Solid Tumors), which is not on this map. Cited by 61 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
61citing papers in PubMed, 1 pooled it
13.3field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02045602 phase1completednot on this map

A Phase I, Multicenter, Open-label, Dose Escalation Study of Intravenous Administration of VCN-01 Oncolytic Adenovirus With or Without Gemcitabine and Abraxane® in Patients With Advanced Solid Tumors

TypeinterventionalSponsorTheriva Biologics SLRan2014 to 2020Enrolled42ConditionsLocally Advanced Solid Tumors, Metastatic Solid Tumors, Pancreatic AdenocarcinomaArmsVCN-01, Gemcitabine, Abraxane®
3 · Its place in the literature

Who cites it

61 citing papers in PubMed, 1 synthesis or guideline pooled it, 79 citations in OpenAlex.

  1. Pooled it
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  7. Understanding and targeting the tumour matrisome.Nature reviews. Clinical oncology · 2026
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  19. Virotherapy as Gene Deliver for Anti-Cancer Therapy: A Review Article.Asian Pacific journal of cancer prevention : APJCP · 2025
    Review
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1 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

24 authors at 10 institutions in 3 countries.

Rocio Garcia-CarboneroOncology Department, Hospital Universitario 12 de Octubre, Instituto de Investigación Sanitaria Hospital 12 de Octubre (imas12), UCM, CNIO, CIBERONC, Madrid, Spain.
Miriam Bazan-PeregrinoVCN Biosciences, Sant Cugat del Vallès, Barcelona, Spain.ORCID 0000-0001-7367-8304
Marta Gil-MartínMedical Oncology Department, Institut Catala d'Oncologia, L'Hospitalet de Llobregat, Barcelona, Spain.
Rafael ÁlvarezCentro Integral Oncológico Clara Campal (CIOCC), Madrid, Spain.
Teresa MacarullaVall d'Hebron University Hospital & Vall d'Hebron Institute of Oncology (VHIO), Barcelona, Spain.
Maria C Riesco-MartinezOncology Department, Hospital Universitario 12 de Octubre, Instituto de Investigación Sanitaria Hospital 12 de Octubre (imas12), UCM, CNIO, CIBERONC, Madrid, Spain.
Helena VerdaguerVall d'Hebron University Hospital & Vall d'Hebron Institute of Oncology (VHIO), Barcelona, Spain.
Carmen Guillén-PonceHospital Ramon y Cajal, Madrid, Spain.ORCID 0000-0002-3594-1084
Martí Farrera-SalVCN Biosciences, Sant Cugat del Vallès, Barcelona, Spain.
Rafael MorenoProgram in Molecular Mechanisms and Experimental Therapy in Oncology (Oncobell), IDIBELL, L'Hospitalet de Llobregat, Barcelona, Spain.
Ana Mato-BercianoVCN Biosciences, Sant Cugat del Vallès, Barcelona, Spain.
Maria Victoria MaliandiVCN Biosciences, Sant Cugat del Vallès, Barcelona, Spain.
Silvia Torres-ManjonProgram in Molecular Mechanisms and Experimental Therapy in Oncology (Oncobell), IDIBELL, L'Hospitalet de Llobregat, Barcelona, Spain.
Marcel CostaProgram in Molecular Mechanisms and Experimental Therapy in Oncology (Oncobell), IDIBELL, L'Hospitalet de Llobregat, Barcelona, Spain.
Natalia Del PozoEpithelial Carcinogenesis Group, Molecular Oncology Programme, Spanish National Cancer Research Centre-CNIO, Madrid, Spain.
Jaime Martínez de VillarrealEpithelial Carcinogenesis Group, Molecular Oncology Programme, Spanish National Cancer Research Centre-CNIO, Madrid, Spain.
Francisco X RealEpithelial Carcinogenesis Group, Molecular Oncology Programme, Spanish National Cancer Research Centre-CNIO, Madrid, Spain.
Noemí VidalDepartment of Pathology, Hospital Universitari de Bellvitge, L'Hospitalet de Llobregat, Spain.
Gabriel CapellaProgram in Molecular Mechanisms and Experimental Therapy in Oncology (Oncobell), IDIBELL, L'Hospitalet de Llobregat, Barcelona, Spain.
Ramon AlemanyProgram in Molecular Mechanisms and Experimental Therapy in Oncology (Oncobell), IDIBELL, L'Hospitalet de Llobregat, Barcelona, Spain.
Emma BlasiVCN Biosciences, Sant Cugat del Vallès, Barcelona, Spain.
Carmen BlascoVCN Biosciences, Sant Cugat del Vallès, Barcelona, Spain.
Manel CascallóVCN Biosciences, Sant Cugat del Vallès, Barcelona, Spain.
Ramon SalazarMedical Oncology Department, Institut Catala d'Oncologia, L'Hospitalet de Llobregat, Barcelona, Spain RamonSalazarSole@iconcologia.net.ORCID 0000-0001-9419-6232
Institut d'Investigació Biomédica de Bellvitge · ESNonagen Bioscience (United States) · USHebron University · PSHospital Universitario 12 De Octubre · ESSpanish National Cancer Research Centre · ESBellvitge University Hospital · ESCentro Oncológico de Galicia · ESHereditary Disease Foundation · USHospital Universitario Ramón y Cajal · ESUniversitat Pompeu Fabra · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundVCN-01 is an oncolytic adenovirus (Ad5 based) designed to replicate in cancer cells with dysfunctional RB1 pathway, express hyaluronidase to enhance virus intratumoral spread and facilitate chemotherapy and immune cells extravasation into the tumor. This phase I clinical trial was aimed to find the maximum tolerated dose/recommended phase II dose (RP2D) and dose-limiting toxicity (DLT) of the intravenous delivery of the replication-competent VCN-01 adenovirus in patients with advanced cancer.

methodsPart I: patients with advanced refractory solid tumors received one single dose of VCN-01. Parts II and III: patients with pancreatic adenocarcinoma received VCN-01 (only in cycle 1) and nab-paclitaxel plus gemcitabine (VCN-concurrent on day 1 in Part II, and 7 days before chemotherapy in Part III). Patients were required to have anti-Ad5 neutralizing antibody (NAbs) titers lower than 1/350 dilution. Pharmacokinetic and pharmacodynamic analyses were performed.

results26% of the patients initially screened were excluded based on high NAbs levels. Sixteen and 12 patients were enrolled in Part I and II, respectively: RP2D were 1×10

conclusionsTreatment with VCN-01 is feasible and has an acceptable safety. Encouraging biological and clinical activity was observed when administered in combination with nab-paclitaxel plus gemcitabine to patients with pancreatic adenocarcinoma. TRIAL REGISTRATION NUMBER: NCT02045602.

Indexed as

AdenocarcinomaPancreatic NeoplasmsAdenoviridaeAlbuminsAntineoplastic Combined Chemotherapy ProtocolsDeoxycytidineGemcitabineHumansHyaluronoglucosaminidasePaclitaxel130-nm albumin-bound paclitaxelAlbuminsDeoxycytidineGemcitabineHyaluronoglucosaminidasePaclitaxelclinical trials as topicgastrointestinal neoplasmsoncolytic virotherapytumor microenvironment

Identifiers

PMID35338084
PMCPMC8961117
OpenAlexW4220993301

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.