Phase 1 Study of BGB-B455 to Evaluate Safety and Dosing in Adults With Advanced or Metastatic Solid Tumors Expressing CLDN6

What this Trial Is About

Researchers are evaluating the safety, tolerability, and recommended dosing of BGB-B455 in adults with advanced or metastatic solid tumors that express the protein claudin 6 CLDN6. This study focuses on how BGB-B455, a bispecific antibody that targets CLDN6 on tumor cells and CD3 on T cells, may trigger an immune response against these tumors. The trial is open-label and consists of two parts Phase 1a for dose escalation and safety expansion, and Phase 1b for dose expansion to assess potential benefits in selected tumor types. Participants will receive increasing doses of BGB-B455 alone in Phase 1a to identify the best dose and evaluate safety. In Phase 1b, participants will receive the recommended dose from Phase 1a either as monotherapy or combined with investigator-selected chemotherapy based on emerging data. The treatment dosing follows protocol guidelines and is carefully monitored throughout the study. Throughout the trial, participants will be closely monitored for adverse events and responses to the treatment. Researchers will assess safety outcomes, including serious adverse events, and measure how the drug behaves in the body pharmacokinetics. Evaluations will include tumor assessments using standard criteria, along with blood tests and biomarker analyses. The study duration can last up to approximately 18 months for response and control rate measurements, with safety monitored up to 7 months after the last dose or start of new therapy.

A Study of BGB-B455 in Adults With Advanced or Metastatic Solid Tumors