Memorial Sloan Kettering Cancer Center
The purpose of this study is to find out whether adding the drug 2141-V11 to standard treatment (anti-PD-1 immunotherapy with or without 5-FU) is a safe treatment approach for participants with advanced esophageal, gastric, or gastroesophageal junction adenocarcinoma
Inclusion Criteria: * Histologically confirmed esophageal, gastric, or gastroesophageal junction adenocarcinoma * Locally advanced unresectable or metastaticdisease at diagnosis * On first line systemic therapy including fluoropyrimidine + anti-PD-1 therapy for advanced GEA (e.g. FOLFOX + nivolumab) for a minimum of 3 months and no more than 9 months. * Platinum chemotherapy included in first line regimen has been discontinued or will be discontinued ≥2 weeks prior to first planned dose of 2141-V11 * Patients in the safety lead-in cohort must be on 5-FU * Primary esophageal, gastric, or…
2141-V11 is a recombinant fully humanized IgG1 monoclonal antibody directed against CD40, which activates the CD40 receptor.
Nivolumab will be given as an intravenous infusion.
5-FU will be administered as a continuous infusion over 48 hours