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

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 Details

NCT ID
NCT07481357
Phase
PHASE1
Sponsor
Dong-A ST Co., Ltd.
Status
RECRUITING
Cancer Type
Pancreatic Cancer
Interventions
  • DA-3501
Locations (sample)
  • Seongnam, Bundang, South Korea|35.48474,129.30505
  • Seongnam, Bundang, South Korea|35.48474,129.30505
  • Seoul, Seoul, South Korea|37.566,126.9784

Key Eligibility Criteria

  • 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

For full eligibility, visit ClinicalTrials.gov.

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