Study of LM-102 in Patients With Advance Solid Tumors

Advanced Solid Tumor Clinical Trial

Official title: A Phase I/II, Open-Label, Multiple Center Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Efficacy of LM-102 Monotherapy or Combination Therapy in Patients With CLDN18.2-Positive Advanced Solid Tumors

Status Terminated

Clinical Trial Summary

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.

Clinical Trial Description

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; ;

Related Conditions & MeSH terms

• Advanced Solid Tumor
• Neoplasms

• NCT number: NCT05008445
• Study type: Interventional
• Source: LaNova Medicines Limited
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: October 6, 2021
• Completion date: February 28, 2023