This is an open-label, multicenter, first-in-human dose escalation and dose expansion study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of BGB-58067 alone, in combination with BG-89894 (discontinued), and in combination with standard of care therapy in participants with advanced solid tumors and with methylthioadenosine phosphorylase (MTAP) deficiency.
Participants must sign the ICF and be capable of giving written informed consent
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 or Karnofsky Performance Scale (KPS) ≥ 70
Life expectancy ≥ 3 months
Evidence of homozygous loss of MTAP or lost MTAP expression in the tumor tissue
Prior treatment with any methylthioadenosine (MTA)-cooperative PRMT5 inhibitor or methionine adenosyltransferase 2a (MAT2A) inhibitor
Active leptomeningeal disease or symptomatic spinal cord compression
Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage
Any malignancy ≤ 2 years before first dose of study drug except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated curatively
BeOne Medicines
Lead sponsor