New drug targets genetic weakness in hard-to-treat stomach cancer
NCT ID NCT05117931
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 2 study tests whether amivantamab can shrink tumors in people with esophagogastric cancer that has a specific genetic change (EGFR or MET amplification). About 25 participants who have already tried at least one other treatment will receive the drug intravenously. The main goal is to see how many patients respond, while also checking for side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- amivantamab
- What this could lead to
- If it works, this could point toward a new treatment option for people with a specific genetic type of esophagogastric cancer that has stopped responding to other therapies.
- What could go wrong
- This is a small, early-phase trial with only 25 participants, so results may not apply to everyone. The drug may cause side effects like infusion reactions, and it is not yet known if it will shrink tumors or improve survival.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 25 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2021
- Expected to finish
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Nov 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Subject or legally authorized representative is willing and able to provide written informed consent. * Patients with previously treated metastatic or unresectable histologically-confirmed esophagogastric cancer who have received at least 1 line of therapy. * EGFR or MET amplification by tissue-NGS with copy number \>8 and/or ctDNA amplification by any FDA and CLIA-approved assay * No prior receipt of an EGFR or MET inhibitor for esophagogastric cancer. (Note: if a patient previously received a EGFR inhibitor, but subsequently demonstrated a MET amplification, or previously received a MET inhibitor, but subsequently demonstrated an EGFR-amplification, inclusion is permitted). * Patients with HER2+ (IHC 3+ or IHC 2+/FISH+) tumors must have progressed on trastuzumab. * Measurable disease based on RECIST 1.1. * ≥ 18 years of age on day of signing informed consent. * Have an ECOG performance status of 0, 1, or 2. * Adequate organ function, defined as: A. Hemoglobin ≥9 g/dL B. ANC ≥1.0 x 10\^9 /L C. Platelets ≥75 x 10\^9 /L D. AST and ALT ≤3 x ULN (≤5 x ULN for subjects with liver metastases) E. Total bilirubin ≤1.5 x ULN; subjects with Gilbert's syndrome can enroll if conjugated bilirubin is within normal limits F. Serum creatinine \<1.5 x ULN or if available, calculated or measured creatinine clearance \>50 mL/min/1.73 m\^2 * Women of childbearing potential and male patients with women of childbearing potential partners must be willing to use an adequate method of contraception Exclusion Criteria: * Prior chemotherapy, targeted small molecule therapy, or biological therapy, within 2 weeks prior to study day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent (excluding alopecia). * If subject received major surgery, they must have recovered adequately prior to starting therapy. * Known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy. * Known active hepatitis B (e.g., HBsAg reactive or polymerase chain reaction detectable). Note: Subjects with a prior history of HBV demonstrated by positive hepatitis B core antibody are eligible if they have at Screening 1) a negative HBsAg and 2) a HBV DNA (viral load) below the lower limit of quantification, per local testing. Subjects with a positive HBsAg due to recent vaccination are eligible if HBV DNA (viral load) is below the lower limit of quantification, per local testing. * Known active hepatitis C (e.g., HCV RNA \[qualitative\] is detected). Note: Subjects with a prior history of HCV, who have completed antiviral treatment and have subsequently documented HCV RNA below the lower limit of quantification per local testing are eligible. * Other clinically active or chronic liver disease. * Subject has uncontrolled inter-current illness, including but not limited to poorly controlled diabetes, ongoing or active infection (i.e., has discontinued all antibiotics for at least one week prior to first dose of study drug), or psychiatric illness/social situation that would limit compliance with study requirements. Subjects with medical conditions requiring chronic continuous oxygen therapy are excluded. * Pulmonary embolism (PE) and deep vein thrombosis (DVT), within 1 month of start of study drug. * Myocardial infarction, unstable angina, stroke, transient ischemic attach (TIA), or coronary/peripheral artery bypass graft, or any acute coronary syndrome within 6 months of start of study drug. * Congestive heart failure defined as New York Heart Association (NYHA) Class III-IV or hospitalization for congestive heart failure (any NYHA class) within 6 months of start of study drug. * Interstitial lung disease (ILD), including drug-induced ILD or radiation pneumonitis requiring treatment with prolonged steroids or other immune suppressive agents that is unresolved or resolved within the last 3 months. * Immune-mediated rash from checkpoint inhibitors that has not resolved prior to enrollment. * Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial, in the opinion of the treating investigator. * Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 6 months after the last dose of trial treatment. * Prisoners, or subjects who are compulsory detained.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Massachusetts General Hospital (Data Collection Only)
Boston, Massachusetts, 02114, United States
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Memorial Sloan Kettering Basking Ridge (Limited protocol activities)
Basking Ridge, New Jersey, 07920, United States
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Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, 07645, United States
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Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065, United States
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Memorial Sloan Kettering Commack (Limited Protocol Activities)
Commack, New York, 11725, United States
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Memorial Sloan Kettering Monmouth (Limited protocol activities)
Middletown, New Jersey, 07748, United States
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Memorial Sloan Kettering Nassau (Limited protocol activities)
Rockville Centre, New York, 11553, United States
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Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, 10604, United States
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University of California, Irvine
Irvine, California, 92697, United States
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