Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 1:23 AM
Study NCT ID:
NCT07481357
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-18
First Post:
2026-02-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
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
Sponsor:
Dong-A ST Co., Ltd.
Organization:
Study Overview
Official 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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: