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RecruitingNCT07481357Updated May 20, 2026

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 Phase 1 interventional study of DA-3501 in Gastric (Stomach) Cancer, GastroEsophageal Cancer and Pancreatic Ductal Adenocarcinoma (mPDAC), sponsored by Dong-A ST Co., Ltd.. Recruiting at 3 sites in South Korea. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2026-05-20.

Sponsored by Dong-A ST Co., Ltd. · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Started May 2026; still recruiting 4 months later.
Phase
Phase 1
Study type
Interventional
Enrollment
51
Allocation
Non-randomized
Ages
19 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Gastric (Stomach) Cancer
  • GastroEsophageal Cancer
  • Pancreatic Ductal Adenocarcinoma (mPDAC)

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03

In context

Stomach Neoplasms

2,851 studies on the registry are indexed under Stomach Neoplasms; 864 are open to participants now.

This study's planned enrollment of 51 is below the median of 67 across 2,096 interventional studies indexed under Stomach Neoplasms.

Browse Stomach Neoplasms studies →

Lead sponsor

Dong-A ST Co., Ltd. is the lead sponsor of 122 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
51 participants (estimated)

Study arms

  • Experimental
    Dose Level 1

    Participants will receive DA-3501 at dose level 1 administered intravenously once every three weeks.

    Drug: DA-3501

  • Experimental
    Dose Level 2

    Drug: DA-3501

  • Experimental
    Dose Level 3

    Drug: DA-3501

  • Experimental
    Dose Level 4

    Drug: DA-3501

  • Experimental
    Dose Level 5

    Drug: DA-3501

  • Experimental
    Dose Level 6

    Drug: DA-3501

  • Experimental
    Dose Level 7

    Drug: DA-3501

  • Experimental
    Dose Level 8

    Drug: DA-3501

  • Experimental
    Dose Level 9

    Drug: DA-3501

  • Experimental
    Dose Level 10

    Drug: DA-3501

  • Experimental
    Dose Level 11

    Drug: DA-3501

Interventions

  • DrugDA-3501

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

06

What researchers measure

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

07

Study locations

3 of 3 sites recruiting
  • CHA University Bundang Medical Center
    Seongnam, Bundang 13496, South Korea
    Recruiting
  • Seoul National University Bundang Hospital
    Seongnam, Bundang 13620, South Korea
    Recruiting
  • Severance Hospital
    Seoul, Seoul 03722, South Korea
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07481357
Lead sponsor
Dong-A ST Co., Ltd.
Responsible party
Sponsor
First posted
Mar 18, 2026
Start date
May 18, 2026
Primary completion
Feb 2028 (estimated)
Completion
Feb 2029 (estimated)
Last update
May 20, 2026

Study contacts

Jiwon Shin
Contact
jiwon_shin@donga.co.kr
82-2-920-8768

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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