A Study of Amivantamab in People With Esophagogastric Cancer (NCT05117931) | Clinical Trial Compass
Active — Not RecruitingPhase 2
A Study of Amivantamab in People With Esophagogastric Cancer
United States25 participantsStarted 2021-12-02
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 ade…