Phase IIIa Study Evaluating DA-3501 for Advanced Gastric, Gastro-Esophageal Junction, and Pancreatic Ductal Adenocarcinomas Assessing Safety, Effectiveness, and Proper Dose Given Every Three Weeks

What this Trial Is About

Researchers are evaluating DA-3501, an investigational drug, in patients with advanced gastric or gastro-esophageal junction adenocarcinoma and advanced pancreatic ductal adenocarcinoma that express the CLDN18.2 protein. This first-in-human phase IIIa study aims to find the maximum tolerated dose MTD or optimal biological effective dose OBED of DA-3501 when given every three weeks, to determine the best recommended dose for further studies. Participants will receive DA-3501 intravenously once every three weeks at assigned dose levels. The study includes multiple dose levels, starting from dose level 1, to evaluate safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy. Tumor assessments and various safety and laboratory tests will be performed according to the study schedule. During the study, participants will undergo tumor evaluations using standardized criteria, safety monitoring including dose-limiting toxicities during the first 21-day cycle, pharmacokinetic and immunogenicity testing, and overall response rate assessments. The study duration depends on treatment cycles and ongoing assessments. Safety and disease status will be monitored throughout, with follow-up continuing as per protocol until study end in February 2029.

A First-In-Human Phase I/IIa Study to Evaluate DA 3501 in Patients With Advanced Gastric or Gastro-esophageal Junction Adenocarcinoma and Pancreatic Ductal Adenocarcinoma