Actively Recruiting
A First-In-Human Phase I/IIa Study to Evaluate DA-3501 in Patients With Advanced Gastric, Gastro-esophageal Junction Adenocarcinoma, and Pancreatic Ductal Adenocarcinoma
Led by Dong-A ST Co., Ltd. · Updated on 2026-05-20
51
Participants Needed
3
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating DA-3501, an investigational drug, in patients with advanced gastric or gastro-esophageal junction adenocarcinoma and advanced pancreatic ductal adenocarcinoma that express the CLDN18.2 protein. This first-in-human phase I/IIa study aims to find the maximum tolerated dose (MTD) or optimal biological effective dose (OBED) of DA-3501 when given every three weeks, to determine the best recommended dose for further studies. Participants will receive DA-3501 intravenously once every three weeks at assigned dose levels. The study includes multiple dose levels, starting from dose level 1, to evaluate safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy. Tumor assessments and various safety and laboratory tests will be performed according to the study schedule. During the study, participants will undergo tumor evaluations using standardized criteria, safety monitoring including dose-limiting toxicities during the first 21-day cycle, pharmacokinetic and immunogenicity testing, and overall response rate assessments. The study duration depends on treatment cycles and ongoing assessments. Safety and disease status will be monitored throughout, with follow-up continuing as per protocol until study end in February 2029.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 19 years or older
- Histologically or cytologically confirmed advanced CLDN18.2 positive gastric, gastro-esophageal junction adenocarcinoma, or pancreatic ductal adenocarcinoma
- Measurable disease using RECIST v1.1 criteria
- Life expectancy of at least 12 weeks as assessed by the investigator
You will not qualify if you...
- Presence of cardiac abnormalities
- Presence of gastrointestinal abnormalities
- Active and clinically significant bacterial, fungal, or viral infections including hepatitis B, hepatitis C, or HIV
- Active systemic infection requiring intravenous antibiotics therapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Repeated 21-day cycles until disease progression or discontinuation.
Participants receive DA-3501 at the assigned dose level administered intravenously once every three weeks.
Infusions every 3 weeks
Trial Site Locations
Total: 3 locations
1
CHA University Bundang Medical Center
Seongnam, Bundang, South Korea, 13496
Actively Recruiting
2
Seoul National University Bundang Hospital
Seongnam, Bundang, South Korea, 13620
Actively Recruiting
3
Severance Hospital
Seoul, Seoul, South Korea, 03722
Actively Recruiting
Research Team
J
Jiwon Shin
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
11
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