Phase 1 Study of GV20-0251 for Treating Advanced or Refractory Solid Tumors Using Intravenous Infusion

What this Trial Is About

Researchers are evaluating the safety of GV20-0251 in adults with advanced or refractory solid tumors. This single-arm, single-center Phase I trial uses a 3 3 dose escalation design involving various cancer types such as hepatocellular carcinoma, cholangiocarcinoma, melanoma, non-small cell lung cancer, pancreatic ductal adenocarcinoma, and others. The study aims to determine the safety profile of GV20-0251 at different dose levels. The trial includes two dose groups 10 mgkg and 20 mgkg, each given every three weeks by intravenous infusion. Patients receive GV20-0251 through a saline bag infusion prepared by study personnel. Dose escalation proceeds based on the occurrence of dose-limiting toxicities during 21-day observation periods. If patients cannot tolerate a dose, adjustments may be made with approval from the clinical trial committee. Participants undergo a screening period lasting up to 28 days before treatment begins. During the study, researchers monitor safety from the first dose for up to two years or until study termination criteria are met. Assessments include calculating individual doses based on body weight and supervising drug administration. The primary outcome is to evaluate the safety of GV20-0251 through careful observation during treatment cycles of 21 days each.

A Study of GV20-0251 in Advanced or Refractory Solid Tumors