Phase 12 Study Evaluating Safety and Anti-Tumor Effects of DB-1324 in Adults With Advanced or Metastatic Gastrointestinal Cancer

What this Trial Is About

Researchers are evaluating DB-1324 in people with advanced or metastatic gastrointestinal tumors in a first-in-human Phase 12 clinical trial. The study aims to understand the safety, tolerability, how the drug moves and acts in the body, the maximum dose that can be tolerated, and the potential antitumor activity of DB-1324. This trial is open-label and multicenter, focusing on participants who have malignant GI tumors that have progressed after standard treatments or have no standard options. Participants will receive DB-1324 intravenously in multiple dosing schedules across different study parts. Phase 1 includes dose escalation, backfill, and dose expansion to find the maximum tolerated dose and recommended doses for later phases. Phase 2 will further explore safety and possible efficacy in selected GI tumor groups. Treatment continues until disease progression, unacceptable side effects, loss of benefit, participant withdrawal, or other stopping criteria. During the study, participants will have evaluations for adverse events, dose-limiting toxicities, and pharmacokinetic measures up to about 30 days after treatment. Researchers will also assess tumor response and survival outcomes over approximately three years. Participants will undergo tumor biopsies or provide archived tissue to measure biomarkers. Safety monitoring, including heart function and organ tests, will be part of the assessments throughout the study.

A Study of DB-1324 in Advanced/Metastatic Gastrointestinal Tumors