Phase III Study of LBL-024 Injection for Treating Patients With Advanced Solid Tumors

What this Trial Is About

Researchers are evaluating the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary efficacy of LBL-024 in patients with advanced malignant tumors in a phase III clinical study. This study includes patients who have failed previous standard treatments, lack standard treatment options, or are not suitable for such treatments. The trial consists of two parts a phase IIIa dose escalation and pharmacokinetic expansion phase, and a phase IIb pivotal single-arm clinical study. Participants receive LBL-024 injections at the maximum tolerated dose every three weeks. The phase IIIa part focuses on dose escalation, safety, and preliminary efficacy, while the phase IIb part serves as a single-arm registry study to further assess the treatment. The study evaluates the drugs pharmacokinetic characteristics and immune response throughout treatment. During the study, participants are closely monitored for dose-limiting toxicities within three weeks of the first dose and maximum tolerated dose completion. Researchers assess objective response rate, adverse events, immunogenicity, disease control rate, and progression-free survival. Follow-up visits occur up to 30 days after treatment discontinuation or withdrawal. The total study duration extends until December 2026.

A Phase I/II Clinical Study of LBL-024 in Patients With Advanced Malignant Tumors