A Study of Amivantamab in People With Esophagogastric Cancer

Conditions

• Esophagogastric Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Amivantamab — DRUG
  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.

Study Details

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.

Key Dates

Start date

Dec 2, 2021

Status verified

Feb 2026

Primary completion

Nov 30, 2026

Completion

Nov 30, 2026

Study Design

Enrollment

25 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Amivantamab
  Patients will receive amivantamab intravenously weekly for the first cycle, and biweekly subsequently at a dose of 1050mg (patients \<80kg) or 1400mg (patients ≥80kg). The initial dose will be administered over 2 days in split doses in order to mitigate the risk of infusion reactions. Therapy will continue for up to 2 years or until progression of disease, initiation of alternative cancer therapy, unacceptable toxicity, or other reason to discontinue treatment occurs-whichever comes first.

Primary Outcome Measure

objective response rate [ Time Frame: 1 year ]

Locations (9)

Find similar trials in Irvine, CA

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