Phase IbII Open-Label Study of LM-108 with Penpulimab and Chemotherapy for Advanced Solid Tumors

What this Trial Is About

Researchers are evaluating the safety, tolerance, and preliminary effectiveness of LM-108 combined with anti-tumor treatments in people with advanced solid tumors. This multicenter, open-label Phase IbII clinical trial focuses on determining the best dose of LM-108 with penpulimab, oxaliplatin, and capecitabine in Phase Ib, and then assessing the combinations effects in Phase II. The study is sponsored by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. Participants receive various drug combinations including LM-108 injection, penpulimab, oxaliplatin, capecitabine, and tislelizumab. These drugs are administered mainly via intravenous infusion on Day 1 of each 21-day treatment cycle, with capecitabine taken orally twice daily from Day 1 to Day 14 or with a specific dosing schedule. Different study groups receive different combinations and doses based on the trial phase and cohort. During the study, participants will be monitored for side effects and treatment responses through lab tests, imaging, and clinical evaluations. Key measurements include dose-limiting toxicities within 21 days of the first dose and progression-free survival over about 10 months. Other outcomes assessed are overall response rate, duration of response, disease control rate, overall survival up to 5 years, and safety events up to 90 days after the last dose. Participants will be followed regularly throughout the treatment cycles and monitored for immunogenicity and drug pharmacokinetics.

Clinical Studies for the Treatment of Advanced Solid Tumors