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 · NCT07481357 · Interventional (participants receive a specific treatment) · Lead sponsor: Dong-A ST Co., Ltd.
View the official record on ClinicalTrials.gov →Interventions studied
DA-3501
What this trial is about
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.
Who can take part
Age range
19 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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
Exclusion criteria
- Cardiac abnormalities
- Gastrointestinal 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.
Where it is running
3 locations listed.
- CHA University Bundang Medical Center - Seongnam, Bundang, South Korea
- Seoul National University Bundang Hospital - Seongnam, Bundang, South Korea
- Severance Hospital - Seoul, Seoul, South Korea