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.
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
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.
Sequential
DA-3501
DrugParticipant will receive DA-3501 at the assigned dose level administered intravenously once every three weeks.
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Treatment groupsSee each treatment group below.
Maximum Tolerated Dose (MTD) based on Dose-Limiting Toxicities (DLTs) during Cycle 1
Optimal Biological Effective Dose (OBED) Based on best Overall Response Rate (ORR)
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