NCT06351020

LM-302 for the Treatment of Subjects With Claudin18.2-Positive Gastric and Gastroesophageal Junction Adenocarcinoma.

A Phase III, Open-Label, Multi Center, Randomized Study of LM-302 Versus Treatment of Physician's Choice (TPC) in Patients With CLDN18.2-Positive, Locally Advanced or Metastatic Gastric(GC) and Gastroesophageal Junction(GEJ) Adenocarcinoma.

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 387 (actual)
• Sponsor: LaNova Medicines Zhejiang Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study will assess the efficacy and safety of LM-302 Versus Treatment of Physician's Choice (TPC) in Subjects With locally advanced or metastatic, Claudin (CLDN) 18.2-positive, Gastric or Gastroesophageal Junction Adenocarcinoma who have progressed on or after 2 lines of systemic therapy

Conditions

• Locally Advanced or Metastatic GC and GCJ Adenocarcinoma

Interventions

Type	Name	Description
DRUG	LM-302	LM-302 intravenous-injection every 2 weeks on Day 1 of each 14-day cycle
DRUG	Apatinib	The subjects will receive Apatinib orally,qd
DRUG	Irinotecan	The subjects will receive Irinotecan intravenous-injection,every 2 weeks on Day 1 of each 14-day cycle

Timeline

• Start date: 2024-06-24
• Primary completion: 2026-11-10
• Completion: 2026-12-15
• First posted: 2024-04-08
• Last updated: 2026-02-06

Locations

2 sites across 1 country: China