Clinical Trials | A Randomized, Multicenter, Open-Label, Phase 2 Study of Givastomig (TJ033721) in Combination with Nivolumab and Chemotherapy versus Nivolumab and Chemotherapy in Participants with Previously Untreated CLDN18.2 Positive and PD-L1 Positive Locally Advanced or Metastatic Gastric, Esophageal, or Gastroesophageal Junction Adenocarcinoma

The University of Virginia is conducting a clinical research study for adults ages 18 and over with untreated CLDN18.2 positive and PD-L1 positive locally advanced or metastatic gastric, esophageal, or gastroesophageal junction adenocarcinoma. The purpose of this research is to test the safety and tolerability of the investigational study drug givastomig, also known as TJ033721, and to determine the best dose of givastomig when given with nivolumab (also known as OPDIVO®) and mFOLFOX (oxaliplatin, leucovorin, and fluorouracil). mFOLFOX is an approved chemotherapy treatment in patients with advanced or metastatic gastric, esopheageal, or gastroesopheaeal junction (GEA) cancers. This research will also test if the combination of the study drug, nivolumab, and chemotherapy may be potentially more beneficial than nivolumab and chemotherapy alone in the treatment of GEA. This study consists of three (3) Arms. You will be participating in only one (1) Arm of the study. You will not be able to choose which Arm you will be in as it will be randomly assigned to you. You will have an equal chance (1:1:1) to get assigned to one of the three Arms. Your study doctor will inform you which Arm you will be assigned to. Within each arm, there are two options for treatment depending on the chemotherapy treatment selected by your study doctor. Study Arms: • Arm 1: o Givastomig at 8mg/kg every 2 weeks with mFOLFOX and nivolumab • Arm 2 o Givastomig at 12 mg/kg every 2 weeks with mFOLOFOX and nivolumab • Arm 3: o Nivolumab and mFOLFOX For participants receiving mFOLFOX, a cycle is every 28 days. Givastomig (at 8 or 12 mg/kg dose), nivolumab, and mFOLOFOX will be administered by an infusion into your vein on Days 1 and 15 of every cycle. You will receive infusions until your disease progresses, you experience side effects that are not tolerable, or decide to withdraw for any other reason. You could receive study treatment for up to 36 cycles or longer. Study-related procedures that are being done beyond your standard of care will be provided at no cost to you or your insurance. [email protected]