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.
NCT07385703 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 752
Last updated 2026-06-25
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
- DRUG
-
LM-302 Injection
The LM-302 injection is an ADC drug targeting CLDN18.2.
- DRUG
-
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.
Sponsors & Collaborators
-
Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-04-15
- Primary Completion
- 2028-10-31
- Completion
- 2030-05-31
Countries
- China
Study Locations
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