NCT07481357RecruitingPhase 1
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
A First-In-Human Phase I/IIa Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of DA 3501 in Patients With Advanced Gastric or Gastro-esophageal Junction Adenocarcinoma and Pancreatic Ductal Adenocarcinoma
Source: ClinicalTrials.gov · Last updated 20 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 51 (estimated)
- First submitted
- 25 Feb 2026
- Start date
- 18 May 2026
- Primary completion date
- Feb 2028
- Lead sponsor
- Dong-A ST Co., Ltd.
- NCT number
- NCT07481357
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 51
- From 18 May 2026 to the primary completion date, Feb 2028
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Cardiac abnormalities
- 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).
- Active systemic infection requiring IV antibiotics therapy.
Other
- Gastrointestinal abnormalities
Who the study is looking for
- Patients aged ≥ 19 years
- Histologically or cytologically documented advanced CLDN18.2+ GC/GEJ adenocarcinoma or advanced CLDN18.2+ PDAC
- Measurable disease as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
- Life expectancy ≥12 weeks as judged by the Investigator
Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Seoul National University Bundang Hospital Coordinator of this site? Confirm its status | Seongnam | South Korea | Recruiting |
| CHA University Bundang Medical Center Coordinator of this site? Confirm its status | Seongnam | South Korea | Recruiting |
| Severance hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.