NCT05117931

A Study of Amivantamab in People With Esophagogastric Cancer

Phase II Study of Amivantamab in EGFR or MET- Amplified Esophagogastric Cancer

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Esophagogastric Cancer

Interventions

Type	Name	Description
DRUG	Amivantamab	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.

Timeline

• Start date: 2021-12-02
• Primary completion: 2026-11-01
• Completion: 2026-11-01
• First posted: 2021-11-11
• Last updated: 2026-02-17

Locations

9 sites across 1 country: United States

Regulatory

• FDA-regulated drug study