Phase 1 Study of CLSP-1025 Given by IV Infusion in Adults With Advanced Solid Tumors Having the p53 R175H Mutation and HLA-A*0201

What this Trial Is About

Researchers are evaluating CLSP-1025, a first-in-class T cell engager targeting the p53 R175H mutation, in adults with advanced solid tumors that have this specific mutation and who are HLA-A*0201 positive. This Phase 1, open-label, multicenter study aims to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and early clinical effects of CLSP-1025 in these patients. The study has two parts Part A focuses on dose escalation to find the recommended doses for further study, while Part B expands the patient group to further evaluate the treatments preliminary anti-tumor activity and safety at the selected doses. CLSP-1025 is given by intravenous infusion to adult patients with advanced solid tumors that have progressed after standard treatments or have no standard treatment options. Participants will undergo evaluations including safety monitoring, blood sampling for drug levels and immune response, and tumor response assessments for up to 24 months after infusion. The primary outcomes include determining the maximum tolerated dose and objective response rate. Secondary outcomes include treatment-related side effects, pharmacokinetic measures, duration of response, progression-free survival, and overall survival, with ongoing safety and activity monitoring throughout the study.

A Study of CLSP-1025 in Adult Patients With Solid Tumors That Harbor the p53 R175H Mutation