NCT07481357

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P50-P75 for phase_1

Timeline
32mo left

Started May 2026

Typical duration for phase_1

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress3%
May 2026Feb 2029

First Submitted

Initial submission to the registry

February 25, 2026

Completed
21 days until next milestone

First Posted

Study publicly available on registry

March 18, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

May 18, 2026

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2029

Last Updated

May 20, 2026

Status Verified

May 1, 2026

Enrollment Period

1.7 years

First QC Date

February 25, 2026

Last Update Submit

May 18, 2026

Conditions

Gastric (Stomach) CancerGastroEsophageal CancerPancreatic Ductal Adenocarcinoma (mPDAC)

Outcome Measures

Primary Outcomes (2)

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

    21 days

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

    42 days

Study Arms (11)

Dose Level 1

EXPERIMENTAL

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

Drug: DA-3501

Dose Level 2

EXPERIMENTAL
Drug: DA-3501

Dose Level 3

EXPERIMENTAL
Drug: DA-3501

Dose Level 4

EXPERIMENTAL
Drug: DA-3501

Dose Level 5

EXPERIMENTAL
Drug: DA-3501

Dose Level 6

EXPERIMENTAL
Drug: DA-3501

Dose Level 7

EXPERIMENTAL
Drug: DA-3501

Dose Level 8

EXPERIMENTAL
Drug: DA-3501

Dose Level 9

EXPERIMENTAL
Drug: DA-3501

Dose Level 10

EXPERIMENTAL
Drug: DA-3501

Dose Level 11

EXPERIMENTAL
Drug: DA-3501

Interventions

DA-3501DRUG

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

Dose Level 1Dose Level 10Dose Level 11Dose Level 2Dose Level 3Dose Level 4Dose Level 5Dose Level 6Dose Level 7Dose Level 8Dose Level 9

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

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

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Central Study Contacts

Jiwon Shin

CONTACT

82-2-920-8768jiwon_shin@donga.co.kr

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 25, 2026

First Posted

March 18, 2026

Study Start

May 18, 2026

Primary Completion (Estimated)

February 1, 2028

Study Completion (Estimated)

February 1, 2029

Last Updated

May 20, 2026

Record last verified: 2026-05

Locations

KR(3)