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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

RecruitingPhase 1Ages 19 Years - anyAllDong-A ST Co., Ltd.
NCT07481357 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Patients aged ≥ 19 years 2. Histologically or cytologically documented advanced CLDN18.2+ GC/GEJ adenocarcinoma or advanced CLDN18.2+ PDAC 3. Measurable disease as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) 4. Life expectancy ≥12 weeks as judged by the Investigator Exclusion Criteria: 1. Cardiac abnormalities 2. Gastrointestinal abnormalities 3. Active and clinically significant bacterial, fungal, or viral infection, including known hepatitis B virus (HBV), known hepatitis C virus (HCV), known human immunodeficiency virus (HIV). 4. Active systemic infection requiring IV antibiotics therapy.
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What it tests

  • DA-3501
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Where

3 sites
CHA University Bundang Medical Center
Seongnam, South Korea
Seoul National University Bundang Hospital
Seongnam, South Korea
Severance Hospital
Seoul, South Korea
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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