Phase 12 Open-Label Study of BHB810 Given by IV Infusion Every 2 Weeks in Adults With Advanced Gastric and Gastroesophageal Junction Adenocarcinoma

What this Trial Is About

Researchers are evaluating the safety and effectiveness of a study drug called BHB810 in adults with advanced gastric and gastroesophageal junction adenocarcinoma, a type of stomach and related cancer. The study aims to understand how the drug works in the body, how it moves through the body, and how the body reacts to it. This is a Phase 12, open-label trial sponsored by BigHat Biosciences, Inc., focusing on treatment for this advanced cancer type. Participants will receive BHB810 through an intravenous IV infusion every two weeks. The study includes several groups dose escalation and backfill cohorts, and two different recommended phase 2 dose levels. These groups will help researchers evaluate different dosing levels and responses to treatment. The study is non-randomized and open-label, meaning all participants receive the study drug. During the study, participants will be closely monitored through regular visits to assess safety, side effects, and how well the drug works. Researchers will measure outcomes such as adverse events, response rates, and how the drug is processed in the body using blood tests and scans. The study also looks at survival and disease progression over time. Participants can expect assessments from the screening phase through the end of treatment, with an average involvement of about six months, and survival monitoring extending up to ten months.

Phase 1/2 Study of BHB810 in Advanced Gastric and GEJ Adenocarcinoma