Phase III Study of IBD0333 to Assess Safety, Tolerability, and Early Effectiveness in Adults With Advanced Solid Tumors or Non-Hodgkin Lymphoma

What this Trial Is About

Researchers are studying the safety, tolerability, and preliminary effectiveness of a drug called IBD0333 in patients with locally advanced or metastatic solid tumors or non-Hodgkin lymphoma. The study includes dose escalation, dose expansion, and clinical exploration phases to find the best dose and explore how well the drug works in specific tumors. Additional goals include understanding how the drug behaves in the body and its immune effects, as well as exploring biomarkers that might predict response to treatment. This is an open, non-randomized phase III trial where patients receive IBD0333 during different study phases. The dose escalation phase determines the maximum tolerated dose and dose limiting toxicity over about one year. The dose expansion phase evaluates the recommended phase 2 dose and safety. During the clinical exploration phase, preliminary efficacy and immunogenicity are assessed. Treatment is given according to study protocols designed to evaluate safety and effectiveness. Participants will undergo regular assessments including monitoring for side effects, laboratory tests for organ function, imaging to evaluate tumor response, and blood tests to study drug levels and immune reactions. Researchers will track outcomes such as tumor response rate, duration of response, and progression-free survival over about one year. Safety and tolerability will be closely observed throughout the study. Total participation time may vary depending on individual treatment and follow-up schedules.

A Clinical Trial to Evaluate Effect of IBD0333 in Patients With Advanced Malignant Tumors