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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
51
Participant will receive DA-3501 at the assigned dose level administered intravenously once every three weeks.
Maximum Tolerated Dose (MTD) based on Dose-Limiting Toxicities (DLTs) during Cycle 1
Time frame: 21 days
Optimal Biological Effective Dose (OBED) Based on best Overall Response Rate (ORR)
Time frame: 42 days
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