biostudies-literatureGarcia-Carbonero RCDTIe003255https://www.ebi.ac.uk/biostudies/studies/S-EPMC8961117biostudies-literatureUnknown10(3)<h4>Background</h4>VCN-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.<h4>Methods</h4>Part 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 bJournal for immunotherapy of cancerPhase I, multicenter, open-label study of intravenous VCN-01 oncolytic adenovirus with or without nab-paclitaxel plus gemcitabine in patients with advanced solid tumors.PMC8961117IDI-20130759Blasi EGil-Martin MMartinez de Villarreal JBazan-Peregrino MCapella GCascallo MFarrera-Sal MMoreno RReal FXAlemany RSalazar RTorres-Manjon SRiesco-Martinez MCDel Pozo NCosta MMacarulla TAlvarez RVidal NGuillen-Ponce CMato-Berciano AGarcia-Carbonero RMaliandi MVBlasco CVerdaguer HfalsePhase I, multicenter, open-label study of intravenous VCN-01 oncolytic adenovirus with or without nab-paclitaxel plus gemcitabine in patients with advanced solid tumors.<h4>Background</h4>VCN-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.<h4>Methods</h4>Part 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 b2022-01-01T00:00:00Z2022 Mar2026-06-15T06:13:13.604Z2026-06-15T03:08:43.915ZS-EPMC89611173533808410.1136/jitc-2021-003255