An Open-label Multicenter Dose Escalation Phase 1b Study to Assess the Safety and Pharmacokinetics of Subcutaneous Delivery of Amivantamab a Human Bispecific EGFR and cMet Antibody for the Treatment of Subjects with Advanced Non-Small Cell Lung Cancer

Brief description of study

The purpose of the study is to determine the safety and antitumor activity of amivantamab delivered subcutaneously (SC) or under the skin with and without the addition of recombinant human hyaluronidase (rHuPH20). We want to select an appropriate dose, dosing schedule, and formulation. The study drug amivantamab is investigational, which means that it has not been approved by the U.S Food and Drug Administration (FDA), the health authority that gives approval for new medicines to be prescribed in the United States, but the FDA has given its permission to test this agent in the current trial.


Clinical Study Identifier: s20-01165
ClinicalTrials.gov Identifier: NCT04606381
Principal Investigator: Joshua K Sabari.
Other Investigators: Barbara Crump, Samantha VanMaanen, Abraham Chachoua, Jessica Wang, Elaine Shum, Salman Rafi Punekar, Sally Lau, Christy Lynn Spalink, David Mendoza, Natalia Cherkassky, Vamsidhar Velcheti, Avital Benson, Melissa L Martinez.


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