This study is designed to evaluate the safety and tolerability of mRNA-2736 in participants with RRMM.
This open-label, Phase 1, dose-escalation, first-in-human (FIH) clinical study of mRNA-2736 in participants with RRMM is designed to evaluate the safety and tolerability of escalating doses of mRNA-2736, administered intravenously (IV), to determine maximum tolerated dose and/or recommended Phase 2 dose, pharmacokinetics, pharmacodynamics, and preliminary efficacy of mRNA-2736.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
mRNA-2736 will be administered IV.
UAB Hospital
Birmingham, Alabama, United States
University of Miami Health System
Miami, Florida, United States
Washington University Medical Center
St Louis, Missouri, United States
Number of Participants Experiencing Adverse Events
Time frame: Up to 1 year
Maximum Plasma Concentration (Cmax)
Time frame: 0 (predose) to 96 hours postdose
Area Under the Concentration-time Curve (AUC)
Time frame: 0 (predose) to 96 hours postdose
Maximum Effect/Concentration of the Expressed Protein (Emax)
Time frame: 0 (predose) to 96 hours postdose
Area Under the Effect Concentration (AUEC)
Time frame: 0 (predose) to 96 hours postdose
Overall Response Rate (ORR)
Time frame: Up to 2 years
Clinical Benefit Rate (CBR)
Time frame: Up to 2 years
Duration of Response (DOR)
Time frame: Up to 2 years
Progression-free Survival (PFS)
Time frame: Up to 2 years
Overall Survival (OS)
Time frame: Up to 3 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Memorial Sloan Kettering Cancer Center
New York, New York, United States
The Mount Sinai Hospital
New York, New York, United States
Ohio State University Hospital
Columbus, Ohio, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
MD Anderson Cancer Center
Houston, Texas, United States
UW Medical Center
Seattle, Washington, United States
...and 3 more locations