Overview
This is a first-in-human Phase I, open-label, multicenter, global, dose-escalation study designed to evaluate the safety, tolerability, and pharmacokinetics of RO7297089 and make a preliminary assessment of anti-tumor activity in patients with R/R MM for whom no established therapy for MM is appropriate and available or who are intolerant to those established therapies.
Eligibility
Inclusion Criteria
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Life expectancy of at least 12 weeks
- R/R MM for which no established therapy for MM is appropriate and available or be intolerant to those established therapies
- Measurable disease
Exclusion criteria:
- Prior use of any monoclonal antibody, radioimmunoconjugate, or antibody-drug conjugate within 4 weeks before first RO7297089 infusion
- Prior treatment with systemic immunotherapeutic agents within 12 weeks or 5 half-lives of the drug, whichever is shorter, before first RO7297089 infusion
- Prior treatment with CAR-T therapy within 90 days before first study drug administration
- Treatment with radiotherapy, any chemotherapeutic agent, or treatment with any other anti-cancer agent (investigational or otherwise) within 4 weeks or 5 half-lives of the drug, whichever is shorter, prior to first RO7297089 infusion
- Autologous stem cell transplantation within 100 days prior to first RO7297089 infusion
- Allogeneic stem cell transplantation within 180 days prior to first RO7297089 infusion or requiring immunosuppression for treatment or prophylaxis of graft versus host disease
- Primary or secondary plasma cell leukemia
- Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection requiring treatment with IV anti-microbial therapy within 14 days prior to first RO7297089 infusion
- Significant cardiovascular disease
- Current CNS involvement by MM