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
Location: See all (3) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 19
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Republic of Korea
CHA University Bundang Medical Center
RECRUITING
Seongnam
Seoul National University Bundang Hospital
RECRUITING
Seongnam
Severance Hospital
RECRUITING
Seoul
Contact Information
Primary
Jiwon Shin
jiwon_shin@donga.co.kr
82-2-920-8768
Time Frame
Start Date: 2026-05-18
Estimated Completion Date: 2029-02
Participants
Target number of participants: 51
Treatments
Experimental: Dose Level 1
Participants will receive DA-3501 at dose level 1 administered intravenously once every three weeks.
Experimental: Dose Level 2
Experimental: Dose Level 3
Experimental: Dose Level 4
Experimental: Dose Level 5
Experimental: Dose Level 6
Experimental: Dose Level 7
Experimental: Dose Level 8
Experimental: Dose Level 9
Experimental: Dose Level 10
Experimental: Dose Level 11
Related Therapeutic Areas
Sponsors
Leads: Dong-A ST Co., Ltd.