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NCT Number: 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

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.

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Key information

Conditions

Gastric (Stomach) Cancer Digestive System Diseases Digestive System Neoplasms GastroEsophageal Cancer Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Pancreatic Ductal Adenocarcinoma (mPDAC) Stomach Diseases Stomach Neoplasms

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

CHA University Bundang Medical Center, Seongnam, Bundang, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

DA-3501

Drug

Participant will receive DA-3501 at the assigned dose level administered intravenously once every three weeks.

Primary outcomes

  1. Maximum Tolerated Dose (MTD) based on Dose-Limiting Toxicities (DLTs) during Cycle 1

    Time frame: 21 days

  2. Optimal Biological Effective Dose (OBED) Based on best Overall Response Rate (ORR)

    Time frame: 42 days

Study contacts

Contact information is provided by the study sponsor or research team.

Jiwon Shin

CONTACT

[email protected]

82-2-920-8768

Sponsors and collaborators

Lead sponsor

Dong-A ST Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Mar 18, 2026
Registry last updated
May 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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