Phase I Open-label Study to Evaluate Safety and Early Effects of Intravenous MBS81V270 Alone or with Pembrolizumab in Adults with Advanced Solid Tumors

What this Trial Is About

Researchers are evaluating the safety, tolerability, pharmacokinetics, and preliminary effectiveness of the drug MBS81V270 in adults with advanced solid tumors. This Phase I, open-label trial includes participants with advanced solid tumors who have no standard treatment options or have declined standard treatments. The study aims to provide data to guide further development of MBS81V270. The trial has two parts Stage I uses a dose escalation design to find the maximum tolerated dose or recommended Phase 2 dose of MBS81V270 administered intravenously. Stage II is an expansion phase with two groups one group receives MBS81V270 combined with pembrolizumab for cutaneous melanoma patients resistant to PD-1 therapy, and the other group receives MBS81V270 alone for uveal melanoma patients previously treated with T-cell engagers. Treatment is given in cycles, with doses adjusted based on safety assessments. Participants undergo plasma cytokine testing, tumor biopsies, and imaging scans MRI or CT to monitor response. Safety is monitored by tracking adverse events and dose-limiting toxicities. Tumor activity is evaluated using RECIST and iRECIST criteria. The study also measures pharmacokinetics and biomarkers related to safety. Participants remain in the trial through treatment cycles and follow-up assessments until study completion.

Safety and Preliminary Efficacy of MBS8(1V270) in Cancer Patients With Advanced Solid Tumours