A Phase 2 Study of AgenT-797 Plus Botensilimab, Balstilimab, Ramucirumab, and Paclitaxel for People With Esophageal, Gastric, or Gastro-esophageal Junction Cancers

Full Title

A Phase II Study of agenT-797 (invariant natural killer T-cells), Botensilimab, a Novel Fc-enhanced CTLA-4 Inhibitor, Plus Balstilimab (anti-PD-1) with Ramucirumab and Paclitaxel for Patients with Previously Treated, Advanced Esophageal, Gastric, or Gastro-esophageal Junction Adenocarcinoma

Purpose

Researchers are assessing a combination of medications to see if they work well against upper digestive cancers. The people in this study have esophagus, stomach, or gastro-esophageal junction cancers that spread and keep growing after treatment.

If you join this study, you will get three investigational drugs (agenT-797, botensilimab, and balstilimab). You will also get two standard medications (ramucirumab and paclitaxel). Given together, these medicines may be more effective at killing cancer cells than when they are given individually.

AgenT-797 is a cellular therapy made of invariant natural killer T cells (iNKT cells) from healthy donors. The iNKT cells help kill cancer cells directly and boost the immune system to kill cancer cells.

Botensilimab and balstilimab take the brakes off the immune response, enabling the immune system to find and kill cancer cells. Ramucirumab inhibits the growth of blood vessels that tumors need to grow and spread. Paclitaxel stops cancer cells from dividing. All of the medications in this study are given intravenously (by vein).

Who Can Join

To join this study, there are a few conditions. You must:

Have esophageal, gastric, or gastro-esophageal junction cancer that keeps growing after treatment.
Not have had prior treatment with ramucirumab nor had serious side effects from immunotherapy. Any prior paclitaxel or docetaxel treatment must have been completed at least 6 months before getting the study therapy.
Be well enough to walk and take care of yourself. You must be able to do activities such as office work or light housework.
Be age 18 or older.