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 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

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07481357

Enrollment

Registered

2026-03-18

Start date

2026-05-18

Completion date

2029-02-01

Last updated

2026-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

DRUGDA-3501

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
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

Countries

South Korea

Contacts

CONTACTJiwon Shin

jiwon_shin@donga.co.kr82-2-920-8768

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 21, 2026