Phase 1 Study of BPI-460372 for Safety and Effectiveness in Adults with Advanced Solid Tumors

What this Trial Is About

Researchers are evaluating BPI-460372, an oral drug, in patients with advanced solid tumors through a phase 1 study. This study aims to assess the safety, tolerability, how the drug moves through the body, and early signs of effectiveness. It involves patients whose cancer has progressed after standard treatments or who have no standard treatment options available. The study is sponsored by Betta Pharmaceuticals Co., Ltd. Participants receive BPI-460372 orally once daily in 21-day treatment cycles. The study has two parts a dose escalation phase where doses increase to find the maximum tolerated dose or recommended dose, and a dose expansion phase where patients receive the identified dose. The drug is given continuously until the disease worsens or other stopping criteria are met. Throughout the study, researchers closely monitor patients for adverse events, dose-limiting toxicities, and drug levels in the body over about 24 months. They evaluate tumor response using imaging and clinical assessments. Participants undergo regular health checks and laboratory tests to track safety and drug effects. The total time of involvement depends on treatment duration and follow-up needs.

A Study of BPI-460372 in Advanced Solid Tumor Patients