Randomized Phase IbIIa Study of SPH4336 Alone or With Cadonilimab for Advanced Solid Tumors Including Liposarcoma

What this Trial Is About

Researchers are evaluating the efficacy and safety of SPH4336 alone or combined with Cadonilimab in patients with advanced solid tumors, including advanced well differentiated or dedifferentiated liposarcoma. This is a randomized, open-label Phase IbIIa clinical trial focused on treatment outcomes for patients who cannot be treated with radical surgery or other local therapies. The study is sponsored by Shanghai Pharmaceuticals Holding Co., Ltd. Participants receive either SPH4336 tablets orally at 400 mg once daily in 28-day cycles, Cadonilimab by intravenous infusion at 6 mgkg every 28 days, or a combination of both. The trial includes a dose expansion phase where measurable lesions are required according to RECIST v1.1. Treatments are administered during the study period, with safety and response monitored throughout. During the study, participants undergo regular assessments including laboratory tests to monitor organ function and adverse events. Researchers measure progression-free survival as the primary outcome over approximately two years. Secondary outcomes include response rates, disease control, overall survival up to eight years, and pharmacokinetic measurements. Participants are monitored for side effects and overall health, with involvement lasting through treatment and follow-up periods.

A Study to Efficacy and Safety of SPH4336 Monotherapy or in Combination With Cadonilimab in Patients With Advanced Solid Tumors.