Phase III Study of VIB305 to Evaluate Safety and Preliminary Effectiveness in Adults With Advanced Solid Tumors

What this Trial Is About

Researchers are evaluating the safety, tolerability, pharmacokinetics, and preliminary efficacy of VIB305, an intravenous drug, in adults with advanced solid tumors that cannot be removed by surgery and who have not responded to or cannot undergo standard treatments. This clinical trial is an open-label, non-randomized study with dose-escalation Phase I and dose-expansion Phase II phases to identify the maximum tolerated dose and recommended dose for further study. Participants receive VIB305 through intravenous infusion once a week, with each treatment cycle lasting three weeks. The study includes six different dose cohorts, with dosing and safety monitored closely during the dose-escalation phase to assess adverse events and dose-limiting toxicities. The dose-expansion phase will further evaluate the drugs safety, pharmacokinetics, immune response, and preliminary anti-tumor activity in selected tumor groups based on earlier results. Throughout the trial, participants will undergo regular assessments including adverse event monitoring, tumor measurements, blood sampling for pharmacokinetic and immunogenicity analysis, and evaluations of treatment response and disease progression. The primary outcomes focus on safety and determining the maximum tolerated dose after the first treatment cycle, while secondary outcomes include immune response, tumor control rates, and pharmacokinetic profiles. Monitoring continues up to 30 days after the last drug administration, with ongoing follow-up to assess treatment effects and participant health.

A Clinical Study to Evaluate the Safety of VIB305 in Patients With Advanced Solid Tumors