A Study Evaluating The Safety And Pharmacokinetics Of Escalating Doses Of RO7297089 In Patients With Relapsed Or Refractory Multiple Myeloma
Refractory Multiple Myeloma, Relapsed Multiple Myeloma
About this trial
This is an interventional treatment trial for Refractory Multiple Myeloma
Eligibility Criteria
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 for the treatment of cancer 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 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
Sites / Locations
- Concord Repatriation General Hospital
- LIVERPOOL HOSPITAL; HAEMATOLOGY; Ingham Institute for Medical Research
- Royal Adelaide Hospital; Haematology Clinical Trials
- St. Vincent's Hospital Melbourne
- Peter Mac Callum Cancer Center
- UZ Gent
- UZ Leuven
- Rigshospitalet
- Vejle Sygehus; Onkologisk Afdeling
- Oslo Universitetssykehus HF; Ullevål sykehus
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Experimental
Arm A Flat Dose Escalation: RO7297089
Arm B Split Dose Escalation: RO7297089
Arm C Step Dose Escalation: RO7297089
Phase I Expansion Stage: RO7297089
Participants in Arm A will receive the target dose of RO7297089 as a flat dose at each scheduled study drug administration visit
Participants in Arm B will receive the first target dose of RO7297089 as a split dose divided over two days (Days 1 and 2). The full target dose will be administered at subsequent study drug administration visits.
Participants in Arm C will receive the first cycle of RO7297089 as a single-step dose escalation. The Cycle 1 Day 1 dose will be lower than the target dose. The full target dose will be administered at subsequent study drug administration visits.
After dose escalation has been completed, approximately 30 patients will be enrolled in the expansion stage. Participants will receive RO7297089 at the recommended phase 2 dose (at or below the maximum tolerated dose).