The purpose of this study is to assess the feasibility of subcutaneous (SC) administration of amivantamab based on safety and pharmacokinetics and determine a dose, dose regimen and formulation for amivantamab SC delivery.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
158
Cedars Sinai Medical Center
West Hollywood, California, United States
Community Health Network
Indianapolis, Indiana, United States
Langone Health at NYC University, NYU School of Medicine
New York, New York, United States
Observed Amivantamab Serum Concentration Immediately Prior to the Next Dose Administration (Ctrough)
Ctrough is the observed amivantamab serum concentration immediately prior to the next drug administration.
Time frame: Up to Day 29
Number of Participants with Adverse Event (AE)
An adverse event is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An adverse event does not necessarily have a causal relationship with the drug. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non investigational) product, whether or not related to that medicinal (investigational or non-investigational) product.
Time frame: Up to 4 years 1 month
Number of Participants with Dose Limiting Toxicity (DLT)
Number of participants with DLT will be assessed.
Time frame: Up to Day 28
Number of Participants with Clinical Laboratory Abnormalities
Number of participants with clinical laboratory (hematology, clinical chemistry, and urinalysis) abnormalities will be assessed.
Time frame: Up to 4 years 1 month
Number of Participants with Anti-amivantamab and Anti-rHuPH20 antibodies
Number of participants with anti-amivantamab and anti-rHuPH20 antibodies will be assessed.
Time frame: Up to 4 years 1 month
Epidermal Growth Factor Receptor (EGFR) Concentrations
EGRF concentrations markers will be assessed.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Participants will receive amivantamab co-formulated with rHuPH20 as SC injection.
Providence Portland Medical Center
Portland, Oregon, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
University Health Network
Toronto, Ontario, Canada
Chungbuk National University Hospital
Cheongju-si, South Korea
Seoul National University Bundang Hospital
Seongnam-si, South Korea
Severance Hospital Yonsei University Health System
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
...and 2 more locations
Time frame: Up to 4 years 1 month
Mesenchymal-Epidermal Transition Tyrosine Kinase Receptor/Hepatocyte Growth Factor Receptor (cMET) Markers
cMET markers will be analyzed.
Time frame: Up to 4 years 1 month
Overall Response Rate (ORR)
ORR defined as the proportion of participants with partial response (PR) or better according to Response Criteria in Solid Tumors (RECIST) v1.1.
Time frame: Up to 4 years 1 month
Part 2: Maximum Amivantamab Dosing Interval Between Time Zero to Steady State
Maximum amivantamab dosing interval Between time zero to steady state will be assessed.
Time frame: Up to 4 years 1 month