Clinical Trial

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

Recruiting Phase 1
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Summary
The goal of this clinical trial is to determine the MTD or OBED of DA-3501 given in Q3W to determine a wRP2D in patients with advanced CLDN18.2 expressing (CLDN18.2+) GC/GEJ and advanced CLDN18.2+ PDAC. Participants will receive the assigned dose once every three weeks and, according to the study procedures, will undergo tumor assessments as well as safety assessments, PK evaluations, and ADA testing.
Protocol Amendment History 2 changes
critical Recruitment opened 2026-05-21
notable Trial sites expanded: 0 -> 3 locations 2026-05-21
Trial Details
NCT Number NCT07481357
Lead Sponsor Dong-A ST Co., Ltd.
Conditions Gastric (Stomach) Cancer, GastroEsophageal Cancer, Pancreatic Ductal Adenocarcinoma (mPDAC)
Enrollment 51 participants
Start Date 2026-05-18
Primary Completion 2028-02 (estimated)
Study Completion 2029-02 (estimated)
Updated on ClinicalTrials.gov 2026-05-20