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Monoclonal Antibodies

Amivantamab for Esophageal Cancer

Phase 2
Recruiting
Led By Steven Maron, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
No prior receipt of an EGFR or MET inhibitor for esophagogastric cancer
Adequate organ function: Hemoglobin ≥9 g/dL, ANC ≥1.0 x 10^9 /L, Platelets ≥75 x 10^9 /L, AST and ALT ≤3 x ULN (≤5 x ULN for subjects with liver metastases), Total bilirubin ≤1.5 x ULN, Serum creatinine <1.5 x ULN or creatinine clearance >50 mL/min/1.73 m^2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

Study Summary

This trial will test amivantamab as a potential treatment for people with EGFR- or MET-amplified esophagogastric cancer. They will look at how effective it is and if it has mild side effects.

Who is the study for?
This trial is for adults with esophagogastric cancer that's spread or can't be removed surgically, who've tried at least one treatment before. They must have specific genetic changes (EGFR or MET amplification) and measurable disease. People with certain heart conditions, other active cancers, uncontrolled illnesses, recent blood clots, liver diseases including hepatitis B or C, lung conditions like ILD, mental health issues affecting trial participation are excluded.Check my eligibility
What is being tested?
Researchers are testing amivantamab to see if it's effective and safe in treating esophagogastric cancer with EGFR or MET gene amplifications. Participants will have had previous treatments and their response to this new drug will be closely monitored.See study design
What are the potential side effects?
While the exact side effects of amivantamab aren't listed here, similar drugs often cause reactions where the drug is injected into the body, skin rashes, fatigue, nausea and potential changes in liver function tests.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have not taken EGFR or MET inhibitors for my esophagogastric cancer.
Select...
My blood counts and liver/kidney functions are within normal ranges.
Select...
My cancer shows EGFR or MET amplification with a high copy number.
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My HER2+ cancer has worsened despite trastuzumab treatment.
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I have esophagogastric cancer that has spread or cannot be removed and have received at least one treatment.
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I am able to get out of my bed or chair and move around.
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I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
objective response rate

Trial Design

1Treatment groups
Experimental Treatment
Group I: AmivantamabExperimental Treatment1 Intervention
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.

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,936 Previous Clinical Trials
588,873 Total Patients Enrolled
Janssen PharmaceuticalsIndustry Sponsor
80 Previous Clinical Trials
205,046 Total Patients Enrolled
Steven Maron, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
1 Previous Clinical Trials
300 Total Patients Enrolled

Media Library

Amivantamab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05117931 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the upper-limit of participants in this research venture?

"Affirmative. Clinicaltrials.gov data corroborates that this clinical experiment, which was first advertised on December 2nd 2021, is actively enrolling participants. Approximately 25 individuals need to be enlisted from 8 distinct medical centres."

Answered by AI

What primary indications is Amivantamab used to treat?

"Amivantamab has been used to successfully treat exons, malignant neoplasms, and conditions caused by prior platinum-based therapy."

Answered by AI

Is this investigation the pioneer in its field?

"Amivantamab has been under research since 2016, when Janssen Research & Development LLC sponsored the first investigation which included 780 participants. Following this initial study, Amivantamab was approved by Phase 1 drug treatment and currently 9 trials are being conducted in 33 countries across 105 cities."

Answered by AI

What other research initiatives have focused on the efficacy of Amivantamab?

"Initially evaluated in 2016, amivantamab has yet to have a completed trial. Nonetheless, there are 9 active investigations taking place worldwide with multiple occurring within Boston, Massachusetts."

Answered by AI

Is Amivantamab a reliable option for patient care?

"Our team has assessed that Amivantamab is likely safe, assigning a score of 2. This conclusion was reached since this clinical trial is in the Phase 2 stage thus there are some safety data but no efficacy records."

Answered by AI

Is enrollment for this research endeavor still available?

"Per the clinicaltrials.gov website, this clinical trial is in progress and actively enrolling participants as of 10/24/2022. Initially posted on 12/2/2021, this research project has been updated since its inception."

Answered by AI

Are any there North American sites participating in this experiment?

"Presently, this clinical trial is taking place at 8 distinct sites. These locations are situated in Boston, New york, and Rockville Centre as well as 5 other cities that may be more convenient depending on the patient's location. Therefore it would beneficial to select a center closest to you if deciding to participate."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study of Amivantamab in People With Esophagogastric Cancer
2021. "A Study of Amivantamab in People With Esophagogastric Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05117931.
All > Debbies Dream > Gastric Cancer
~10 spots leftby Nov 2025
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