The purpose of this study is to see whether the study drug, amivantamab, is an effective treatment for people with EGFR- or MET-amplified esophagogastric cancer. The researchers will also look at whether amivantamab is a safe treatment that causes few or mild side effects in participants.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
Patients will receive amivantamab weekly for the first cycle, and biweekly subsequently at a dose of 1050mg (\<80kg) or 1400mg (\>80kg). The first day of dosing is considered Cycle 1 Day 1. Each cycle is 28 days in duration. The initial dose will be administered over 2 days to prevent infusion reactions. For patients who weigh \<80 kg, amivantamab 350mg IV will be given on Cycle 1 Day 1, and the remaining 700mg IV will be given on Cycle 1 Day 2. Patients will continue to receive amivantamab 1050mg IV once a week during Cycle 1 then biweekly (Days 1 and 15) of each subsequent Cycle. For patients who weigh ≥ 80 kg, 350mg IV amivantamab will be given on Cycle 1 Day 1 and 1050mg IV will be given on Cycle 1 Day 2. Patients will continue to receive amivantamab 1400mg IV once a week during Cycle 1 then biweekly (Days 1 and 15) of each subsequent Cycle.
University of California, Irvine
Irvine, California, United States
Massachusetts General Hospital (Data Collection Only)
Boston, Massachusetts, United States
Memorial Sloan Kettering Basking Ridge (Limited protocol activities)
Basking Ridge, New Jersey, United States
objective response rate
ORR; defined as complete response (CR) or partial response (PR)) by RECIST 1.1 criteria
Time frame: 1 year
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Memorial Sloan Kettering Monmouth (Limited protocol activities)
Middletown, New Jersey, United States
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, United States
Memorial Sloan Kettering Commack (Limited Protocol Activities)
Commack, New York, United States
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, United States
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, United States
Memorial Sloan Kettering Nassau (Limited protocol activities)
Rockville Centre, New York, United States