Phase 1 Study to Assess Safety, Tolerability, and Early Anti-Tumor Effects of CMAB017 in Adults with Advanced Solid Tumors

What this Trial Is About

Researchers are evaluating the safety, tolerability, pharmacokinetics, and preliminary anti-tumor effects of CMAB017 in patients with advanced malignant solid tumors. This multicenter, open-label phase Ia study aims to better understand how this drug behaves in the body and its potential impact on various solid tumors where standard treatments have failed, are unavailable, or refused. Participants receive CMAB017 administered intravenously either every two weeks or every three weeks during the core study period, which includes the first four doses. After completing this period and dose escalation, those showing therapeutic effects and tolerable side effects may continue treatment in an extension period. This extension phase allows further assessment of long-term safety, drug behavior in the body, immune response, and anti-tumor activity. Throughout the study, participants will undergo regular evaluations, including blood tests to monitor drug levels and immune responses, as well as safety checks for adverse effects. Researchers will measure dose limiting toxicities and maximal tolerated dose up to 12 weeks, along with secondary measures such as blood concentration levels and antibody formation over up to one year. The total study period includes core and extension phases to observe both short- and long-term outcomes.

Safety and Tolerability of CMAB017 In Patients With Advanced Solid Tumors