Brief Summary
The goal of this clinical trial is to learn if BGB-B455 can treat advancedat a late stage, far along or metastatic solid tumors expressing claudin 6 (CLDN6), a protein that is found on some tumors.
The main questions it aims to answer are:
- What is the recommended dosing for BGB-B455?
- What medical problems do participants have when taking BGB-B455?
The study has two parts:
- Phase 1a: dosethe amount of medication taken escalation and safety expansion
- Phase 1b: dose expansion
Intervention / Treatment
- Drug: BGB-B455
Inclusion Criteria:
- Histologically or cytologically confirmed advanced or metastatic, and unresectable solid tumors who have previously received standard systemic therapy for advanced or metastatic disease or for whom treatment is not available or not tolerated.
- Agreement for collection of formalin-fixed paraffin-embedded (FFPE) tumor tissuea group of cells that work together to perform a function for central CLDN6 testing and other biomarker assessments.
- Tumor CLDN6 expression (CDLN6+) by central immunohistochemistry testing is required for Phase 1a dose escalation Cohort 5 and higher.
- ≥ 1 measurable lesion as assessed by RECIST v1.1.
- Stable Eastern Cooperative Oncologythe study, diagnosis and treatment of cancer Group (ECOG) Performance Status of 0 or 1.
- Adequate organ function.