The objective of this study is to assess the safety, efficacy, and pharmacokinetics of MRG002, as well as the immunogenicity as defined by the incidence of anti-drug antibody (ADA) of MRG002 in patients with HER2-positive advanced solid tumors and locally advanced or metastatic gastric/gastroesophageal junction (GEJ) cancer.
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Maximum Tolerated Dose (MTD)
Timeframe: DLT will be evaluated during the first 21-day treatment cycle (Cycle 1)
Recommended Phase II Dose (RP2D)
Timeframe: Day 1 to Day 21 of Cycle 1
Objective Response Rate (ORR)
Timeframe: Baseline to study completion (24 months)
Incidence of Adverse Events (AEs)
Timeframe: After signing informed consent until 45 days after the last dose of MRG002