This study will evaluate the safety, tolerability, and pharmacokinetics of Runimotamab administered intravenously as a single agent and in combination with Trastuzumab in participants with locally advanced or metastatic Human Epidermal Growth Factor Receptor 2 (HER2)-expressing cancers.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
123
Runimotamab will be administered via IV infusion until disease progression, intolerable toxicity, or any other discontinuation criteria are met.
Trastuzumab will be administered via IV infusion
Participants will receive IV tocilizumab if needed
Percentage of Participants with Adverse Events
Time frame: From baseline through end of study (approximately 78 months)
Serum Concentration of Runimotamab
Time frame: At predefined intervals from Cycle 1, Day 1 (approximately 1 year)
Area Under the Serum Concentration vs. Time Curve (AUC) of Runimotamab
Time frame: At predefined intervals from Cycle 1, Day 1 (approximately 1 year)
Maximum Observed Serum Concentration (Cmax) of Runimotamab
Time frame: At predefined intervals from Cycle 1, Day 1 (approximately 1 year)
Minimum Observed Serum Concentration (Cmin) of Runimotamab
Time frame: At predefined intervals from Cycle 1, Day 1 (approximately 1 year)
Clearance (CL) of Runimotamab
Time frame: At predefined intervals from Cycle 1, Day 1 (approximately 1 year)
Volume of Distribution at Steady State (Vss) of Runimotamab
Time frame: At predefined intervals from Cycle 1, Day 1 (approximately 1 year)
Objective Response (OR) as Determined by the Investigator According to Response Evaluation Criteria In Solid Tumors v1.1 (RECIST v1.1)
Time frame: Baseline through the end of study (approximately 78 months)
Duration of Response (DOR)
Time frame: From the first occurrence of a documented objective response to first documented disease progression or death from any cause, through the end of the study (approximately 78 months)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Yale University
New Haven, Connecticut, United States
Washington University
Saint Louis, Michigan, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
SCRI Oncology Partners
Nashville, Tennessee, United States
MD Anderson Cancer Center
Houston, Texas, United States
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia
Grand Hopital de Charleroi asbl
Charleroi, Belgium
Princess Margaret Hospital
Toronto, Ontario, Canada
Rigshospitalet-Blegdamsvej 9
Copenhagen, Denmark
EDOG - Institut Bergonie - PPDS
Bordeaux, Gironde, France
...and 17 more locations
Anti-Drug Antibody (ADA) Levels of Runimotamab
Time frame: At predefined intervals from Cycle 1, Day 1 (approximately 1 year)