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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
27
RO7297089 will be given via intravenous (IV) infusion
Concord Repatriation General Hospital
Concord, New South Wales, Australia
LIVERPOOL HOSPITAL; HAEMATOLOGY; Ingham Institute for Medical Research
Liverpool, New South Wales, Australia
Royal Adelaide Hospital; Haematology Clinical Trials
Adelaide, South Australia, Australia
Percentage of Participants With Adverse Events (AEs), Including Dose Limiting Toxicities (DLTs)
Adverse event severity graded according to NCI CTCAE v5.0
Time frame: Baseline up to 1 year 7 months
Time to Maximum Concentration Observed (Tmax) of RO7297089
Time frame: Cycle 1 Day 1
Area Under the Curve (AUC) of RO7297089
Time frame: Cycle 1 Day 1
Maximum Concentration Observed (Cmax) of RO7297089
Time frame: Cycle 1 Day 1, Cycle 2 Day 8
Minimum Concentration Observed (Cmin) of RO7297089
Time frame: Cycle 1 Day 1, Cycle 2 Day 8
Half-life (t1/2) of RO7297089
Time frame: Cycle 1 Day 1
Objective Response Rate (ORR)
ORR is defined as a Stringent Complete Response (Scr), Complete Response (CR), Very Good Partial Response (VGPR) or Partial Response (PR) as determined by the Investigator according to International Myeloma Working Group (IMWG) Uniform Response Criteria
Time frame: Baseline up to approximately 19 months
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Oslo Universitetssykehus HF; Ullevål sykehus
Oslo, Norway