Phase 1 Multicenter Study Evaluating Safety and Tolerability of SBO-154 in Adults with Advanced Solid Tumors

What this Trial Is About

Researchers are conducting a Phase 1 study to evaluate the safety and tolerability of SBO-154 in adults with advanced solid tumors who have either not responded to or cannot tolerate standard treatments. The study aims to find the highest dose of SBO-154 that patients can safely tolerate and then further assess its safety in specific advanced cancers. The study is divided into two parts. In Part 1, participants receive escalating doses of SBO-154 administered intravenously every three weeks to determine the maximum tolerated dose. In Part 2, the safety of the selected doses from Part 1 is further evaluated in patients with particular types of advanced solid tumors. Treatment continues with dosing every three weeks during the study period. Participants will be closely monitored through scheduled visits involving laboratory tests and assessments to track any dose-limiting toxicities and treatment-related adverse events up to 30 days after the last dose. Researchers will also evaluate tumor response using imaging every six weeks for up to 12 months and monitor the presence of anti-drug antibodies for up to one year. The overall study duration extends through 2030, with ongoing safety and response evaluations.

A Study to Test the Safety and Tolerability of SBO-154 in Patients With Advanced Solid Tumors.