First-in-human dose study of DA-3501 for CLDN18.2-positive stomach, GEJ cancer, and pancreatic cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This early-phase trial evaluates DA-3501 in patients with advanced CLDN18.2-expressing gastric/GEJ adenocarcinoma or pancreatic ductal adenocarcinoma. Participants receive DA-3501 every three weeks, with tumor assessments, safety monitoring, pharmacokinetics, and anti-drug antibody testing to determine the maximum tolerated dose and recommended phase 2 dose. The study uses a standard dose-escalation approach in a population with limited treatment options. Eligible patients have measurable disease, adequate life expectancy, and no active significant infections or major cardiac or GI issues. Lead sponsor is Dong-A ST, with participating centers in Bundang and Seoul, Korea.

Why it matters

Who can join: the full rules

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.

Where it's running

• CHA University Bundang Medical Center
  Seongnam, Bundang, South Korea Recruiting
• Seoul National University Bundang Hospital
  Seongnam, Bundang, South Korea Recruiting
• Severance Hospital
  Seoul, Seoul, South Korea Recruiting

Study contacts

• Study coordinator: Jiwon Shin
• Email: jiwon_shin@donga.co.kr
• Phone: 82-2-920-8768

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.