Phase III Trial of N-3C01 Alone or With PD-L1 Antibody for Advanced Solid Tumors Evaluating Safety and Treatment Response

What this Trial Is About

Researchers are evaluating the safety, tolerability, and effectiveness of a drug called N-3C01, given by subcutaneous injection alone or combined with a PD-L1 monoclonal antibody, in adults with advanced solid tumors. This Phase III study includes a dose escalation phase for both the single drug and the combination, followed by an expansion phase focusing on the combination therapy in selected patient groups. In Phase I, participants receive N-3C01 either alone or together with a fixed dose of PD-L1 antibody, to find the maximum tolerated dose and the recommended dose for Phase II. The drug is given by subcutaneous injection every 2 or 3 weeks. In Phase II, participants receive the recommended dose of N-3C01 combined with the PD-L1 antibody. One treatment option includes pembrolizumab administered intravenously every 3 weeks alongside N-3C01. Participants will be closely monitored for safety throughout the study, including evaluation of toxicities, adverse events, vital signs, ECGs, blood and urine tests, and thyroid function, up to about 24 months. Researchers will also assess how the body processes the drug, immune responses, tumor response, progression-free survival, and overall survival. Study visits and safety follow-up will continue for up to two years after treatment begins to ensure thorough observation.

N-3C01 Monotherapy and Combination With PD-(L)1 Inhibitors in Advanced Solid Tumors