NCT07481357 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
| NCT ID | NCT07481357 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Dong-A ST Co., Ltd. |
| Condition | Gastric (Stomach) Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 51 participants |
| Start Date | 2026-05-18 |
| Primary Completion | 2028-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 51 participants in total. It began in 2026-05-18 with a primary completion date of 2028-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07481357 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, studying Gastric (Stomach) Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07481357 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07481357 currently recruiting?
Yes, NCT07481357 is actively recruiting participants. Contact the research team at jiwon_shin@donga.co.kr for enrollment information.
Where is the NCT07481357 trial being conducted?
This trial is being conducted at Seongnam, South Korea, Seongnam, South Korea, Seoul, South Korea.
Who is sponsoring the NCT07481357 clinical trial?
NCT07481357 is sponsored by Dong-A ST Co., Ltd.. The trial plans to enroll 51 participants.
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