This study includes phase I dose escalation and phase II dose expansion.~Phase I dose escalation consists of LM-102 monotherapy dose escalation (Part Ia) and LM-102 combination dose escalation (Part Ib):~Part Ia is LM-102 monotherapy dose escalation, will be conducted among the subjects with recurrent or refractory advanced solid tumors to determine the RP2D of LM-102 monotherapy;Statistical designs include an initial accelerated titration at the first dose level followed by the i3+3 design at other four dose levels ; Part Ib is the dose escalation of LM-102 combined with SOC, will be conducted in the subjects with advanced gastric and gastroesophageal junction adenocarcinoma(GC/GEJ), pancreatic cancer (PC)and biliary tract carcinoma(BTC), respectively in first setting or second setting, to explore the recommended dose of LM-102 in combination SOC for dose expansion, 4 cohorts are planned;~Phase II dose expansion consists of LM-102 monotherapy dose escalation (Part IIa) and LM-102 combination dose escalation (Part IIb):~Part IIa is the dose expansion of LM-102 monotherapy, 3 cohorts are planned in the subjects with CLDN18.2 positive, recurrent or refractory advanced GC/GEJ , PC , BTC , to explore the preliminary efficacy of LM-102 monotherapy in the target tumor types； Part IIb is the dose expansion of LM-102 in combination with SOC, 4 cohorts are planned in the subjects with advanced, CLDN18.2 positive, treatment naïve GC/GEJ, PC, BTC, and in the subjects with GC/GEJ who have progressed on first line treatment, with the aim to to explore the preliminary efficacy of LM-102 monotherapy in the target tumor types;
This is an open label Phase I/II trial of LM-102 injection, a recombinant humanized monoclonal antibody targeting Claudin 18.2 (CLDN18.2). It is being tested in advanced solid tumors including gastric cancer/gastroesophageal junction adenocarcinoma, Pancreatic Cancer, Biliary Tract Cancer, esophageal adenocarcinoma and ovarian mucous carcinoma.