Phase III Study of LM-168 Alone or With Toripalimab for Advanced Solid Tumors Evaluating Safety, Dosage, and Preliminary Effectiveness

What this Trial Is About

Researchers are evaluating LM-168 alone or in combination with toripalimab in people with advanced solid tumors. This phase III study aims to assess the safety, tolerability, and best dose of LM-168 and to look at its initial anti-tumor effects by measuring objective response rate. The study is open-label and includes dose escalation and expansion phases to gather important information about these treatments in this patient population. Participants will receive LM-168 by intravenous drip every three weeks, either alone or combined with toripalimab, also given intravenously every three weeks. The study includes a dose escalation stage to find the recommended phase 2 dose or maximum tolerated dose, followed by a dose expansion stage to further evaluate safety and effectiveness. Both single-agent and combination treatments are studied in different groups. During the study, participants will have regular monitoring including vital signs like temperature, pulse, and blood pressure, as well as laboratory tests such as blood routine, urine routine, blood biochemistry, coagulation function, and thyroid function. Heart function tests including echocardiography and electrocardiograms will be performed. The Eastern Cooperative Oncology Group ECOG performance status and tumor response will be assessed over a follow-up period extending up to 130 weeks. Safety, tolerability, pharmacokinetics, and preliminary efficacy are key outcomes being measured throughout the trial.

A Study of LM-168 as a Single Agent or in Combination With Toripalimab in Subjects With Advanced Solid Tumours