NCT07385703

Clinical Study on the Efficacy and Safety of LM-302 Injection Combined With Tislelizumab and Tislelizumab Combined Chemotherapy for the Treatment of Gastric or Gastroesophageal Junction Adenocarcinoma.

A Randomized, Open-Label, Multicenter Phase III Study of Tecotabart Vedotin Plus Tislelizumab Versus Tislelizumab Plus Chemotherapy as First-Line Treatment in Patients With CLDN18.2-Positive, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 752 (estimated)
• Sponsor: Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study primarily evaluates the efficacy and safety of the LM-302 plus tislelizumab regimen versus tislelizumab plus chemotherapy in the treatment of previously untreated locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma patients with CLDN18.2 positivity.

Conditions

• Adenocarcinoma

Interventions

Type	Name	Description
DRUG	LM-302 Injection	The LM-302 injection is an ADC drug targeting CLDN18.2.
DRUG	Tislelizumab	Tislelizumab is a humanized monoclonal antibody targeting programmed cell death receptor-1 (PD-1).
DRUG	Oxaliplatin Injection	Oxaliplatin injection is a platinum-based antitumor drug.
DRUG	Capecitabine Tablets	Capecitabine tablets belong to the fluorouracil-class prodrugs.

Timeline

• Start date: 2026-03-01
• Primary completion: 2028-10-01
• Completion: 2030-05-01
• First posted: 2026-02-04
• Last updated: 2026-02-04

Locations

106 sites across 1 country: China