NCT07529808

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

Phase 1/2, Open-Label, Multicenter, Dose Escalation and Expansion Study of BHB810 in Participants With Advanced Gastric and Gastroesophageal Junction Adenocarcinoma

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 164 (estimated)
• Sponsor: BigHat Biosciences, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is looking at how safe BHB810 is in adults with gastroesophageal adenocarcinoma (GEA) and other gastrointestinal (GI) cancers. The purpose of this study is also to look at: how well the study drug works, how the study drug moves into, through, and out of the body, and how your body reacts to the study drug. Participants will get an IV infusion of BHB810 every 2 weeks while on study treatment.

Conditions

• Gastric Cancer
• Gastric Adenocarcinoma
• Gastric (Stomach) Cancer
• Gastroesophageal Adenocarcinoma
• Gastroesophageal Cancer (GC)
• Gastroesophageal Junction (GEJ) Adenocarcinoma
• Gastroesophageal Junction (GEJ) Cancer
• Gastrointestinal Cancer Metastatic
• Gastrointestinal Adenocarcinoma
• Gastrointestinal Cancers
• Colorectal (Colon or Rectal) Cancer
• Pancreatic Cancer
• CDH17-positive Advanced Solid Tumors
• Advanced Gastric Cancer

Interventions

Type	Name	Description
DRUG	BHB810	Every 2 weeks IV administration

Timeline

• Start date: 2026-06-01
• Primary completion: 2028-12-01
• Completion: 2028-12-01
• First posted: 2026-04-14
• Last updated: 2026-04-15

Regulatory

• FDA-regulated drug study