Phase 1 Study of VET3-TGI Alone and With Atezolizumab for Advanced Solid Tumors

What this Trial Is About

Researchers are evaluating VET3-TGI, an oncolytic immunotherapy designed to treat advanced solid tumors by infecting and killing cancer cells while sparing healthy cells. This Phase 1 dose escalation and expansion study aims to find a safe and effective dose of VET3-TGI administered either directly into tumors or intravenously, alone or combined with atezolizumab, in patients with various advanced solid tumors who have limited treatment options. The study includes four groups Group A tests VET3-TGI alone by direct tumor injection Group C tests VET3-TGI alone by intravenous infusion Groups B and D combine VET3-TGI at the highest tolerated doses from Groups A and C with atezolizumab, an anti-PD-L1 antibody, given intravenously. Booster doses or infusions of VET3-TGI and atezolizumab may continue for up to two years. After determining the highest tolerated doses, up to 15 additional patients may be enrolled to further assess VET3-TGIs effects. Participants will undergo regular monitoring of safety through adverse event tracking and dose limiting toxicity assessments over several weeks and months. Researchers will evaluate tumor responses, disease control, progression, survival, immune changes in tissues and blood, and viral delivery kinetics. The study spans up to 108 months to capture long-term outcomes and safety, with participants expected to comply with study procedures and follow-up care throughout the treatment and observation periods.

A Study of VET3-TGI in Patients With Solid Tumors