Phase I Study of SIBP-A19 Injection for Safety and Effectiveness in Adults with Advanced Malignant Solid Tumors

What this Trial Is About

Researchers are evaluating the safety, tolerability, and how the body processes SIBP-A19 injection in people with advanced or metastatic solid tumors. The study aims to find the highest dose patients can tolerate and the best dose for further study, while also looking at early signs of anti-tumor effects and possible biomarkers. This Phase 1 open-label trial is conducted at multiple centers and includes participants without effective standard treatment options. The trial has three stages dose escalation, dose expansion, and indication expansion. During dose escalation, participants receive increasing doses of SIBP-A19 ranging from 1.0 to 8.0 mgkg given by intravenous infusion every 21 days to find the maximum tolerated dose. The dose expansion phase enrolls additional participants at selected doses to further evaluate safety and effects. In the indication expansion phase, the recommended Phase II dose is tested in specific tumor groups with at least 30 participants per group. Participants will be closely monitored with assessments including adverse events from the first dose through 28 days after the last dose, evaluations of dose-limiting toxicities, and pharmacokinetic measurements at multiple time points. Researchers will also assess tumor responses and survival outcomes about six weeks after final evaluations. Safety follow-up continues throughout the study to understand the treatments impact and identify an appropriate dose for future research.

A Clinical Trial of SIBP-A19 Injection in the Treatment of Advanced Malignant Solid Tumor Patients