Phase II Study of LM-24C5 with Other Treatments for CEACAM5-positive Advanced Solid Tumors A Multicenter Open-label Study to Assess Safety and Effectiveness

What this Trial Is About

Researchers are evaluating the efficacy and safety of LM-24C5 combined with other anti-tumor treatments in people with CEACAM5-positive advanced solid tumors. This Phase II study aims to better understand how the combination therapy works and its tolerability in patients who have recurrent or refractory advanced solid tumors or who cannot use standard therapies. The study is sponsored by LaNova Medicines Limited and focuses on measuring tumor response over a period of 110 weeks. Participants will receive LM-24C5 given intravenously every two weeks alongside other anti-tumor therapies such as Penpulimab, Docetaxel, Trifluridine and Tipiracil Hydrochloride tablets taken orally twice daily, and Bevacizumab injections. Different combinations of these drugs will be studied to assess their combined effects. The study does not use randomization or blinding, and all participants will receive the experimental treatment combinations throughout the trial. During the study, participants will undergo regular assessments including tumor evaluations to measure objective response rates and anti-tumor activity. Blood samples will be collected to analyze pharmacokinetic parameters and immunogenicity at baseline and at intervals up to 110 weeks. Researchers will also study the relationship between tumor markers like CEACAM5 and PD-L1 expression and treatment effects. Safety and tolerability will be closely monitored throughout the trial duration, which extends nearly three years.

Phase II Study of LM-24C5