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LM-302 and Tislelizumab Treatment for CLDN18.2-Positive Gastric or Gastroesophageal Junction Adenocarcinoma

Study Aim

This study aims to compare the effectiveness of LM-302 and Tislelizumab treatment versus Tislelizumab and chemotherapy in improving progression-free survival for patients with previously untreated, locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma who have PD-L1-positive status and high CLDN18.2 expression.

What is being tested

LM-302 Injection

+ Tislelizumab

+ Oxaliplatin Injection

Drug

Who is being recruted

Adenocarcinoma+2

+ Carcinoma

+ Neoplasms

Over 18 Years

+20 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 3

Interventional

Study Start: March 2026

See protocol details

Summary

Principal SponsorShanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd.

Study ContactLin Shen, Doctor

Last updated: February 5, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2026

Actual date on which the first participant was enrolled.

This study focuses on treating a specific type of stomach or gastroesophageal junction cancer that is locally advanced, unresectable, or metastatic and tests positive for CLDN18.2. The main goal is to evaluate the effectiveness and safety of a new treatment combination, Tecotabart Vedotin (LM-302) plus Tislelizumab, compared to the current standard treatment, Tislelizumab plus chemotherapy. The hope is that this new combination will offer improved care for patients with this form of cancer. During the study, participants will receive either the new treatment combination or the standard treatment. The study's primary outcome is to compare the progression-free survival (PFS) between these two groups. Progression-free survival refers to the length of time during and after the treatment that a patient lives with the disease but it does not get worse. The study will assess PFS using independent central review following established criteria in evaluating solid tumors.

Official TitleA 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

NCT07385703

Principal SponsorShanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd.

Study ContactLin Shen, Doctor

Last updated: February 5, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

752 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

AdenocarcinomaCarcinomaNeoplasmsNeoplasms by Histologic TypeNeoplasms, Glandular and Epithelial

Criteria

11 inclusion criteria required to participate

Willing and able to comply with the study's visit schedule, treatment plan, laboratory tests, and other research procedures.

Age ≥ 18 years.

Histologically or cytologically confirmed adenocarcinoma of the stomach or gastroesophageal junction.

For locally advanced unresectable or metastatic adenocarcinoma of the stomach or gastroesophageal junction that has not previously received any systemic treatment: Patients who have previously received radical neoadjuvant chemotherapy or adjuvant chemotherapy (radiotherapy) based on a platinum-based combination chemotherapy regimen and have not developed distant metastasis or local recurrence within 6 months after completion of treatment can be included. The calculation of a 6-month interval is defined as recurrence within the same date range after 6 months. For example, if the end date of the last treatment is January 1, the 6-month period from that date refers to January 1 to July 1 (including July 1). Alternatively, if the end date of the last treatment is August 31, the 6-month period from that date refers to August 31 to February 28 (or February 29 in leap years).

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9 exclusion criteria prevent from participating

There are gastric cancer lesions confirmed by imaging that are accompanied by cavities or necrosis, and are closely related to major blood vessels, and are assessed by the researchers as posing a high risk of major bleeding.

Patients with known central nervous system (CNS) metastases. Patients with non-meningeal, midbrain, pontine, or spinal cord metastases who are judged by the investigator to have stable brain metastases can be enrolled. Stable brain metastases are defined as patients whose brain metastases have undergone treatment and the condition of the metastases has stabilized (brain imaging examination at least 28 days before randomization shows stable lesions, no neurological symptoms, and no immediate need for local or systemic treatment within 14 days before randomization), with no evidence of new or previously existing brain metastases enlarging.

Clinically uncontrollable third-space effusion, such as moderate or greater volume, requiring long-term catheterization, previous history of intestinal obstruction or paralysis, compartmented ascites, undergoing or planning to undergo local treatment (including drainage, peritoneal shunt, or cell-free concentrated ascites reinfusion therapy) within 14 days prior to screening, or significant increase within 2 weeks after local treatment, meeting any of the above criteria or deemed unsuitable for enrollment by the investigator.

Patients with symptomatic spinal cord compression, or those who are expected to develop symptoms of spinal cord compression if left untreated; or for patients with previously diagnosed and treated spinal cord compression, there is no evidence indicating that the disease was clinically stable for ≥4 weeks before the first study drug administration; except for patients with asymptomatic spinal cord compression indicated by imaging, who are assessed as stable by a specialist and do not require treatment for spinal cord compression at this time.

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

LM-302 Injection combined with Tislelizumab, 14days as a treatment cycle.

Group II

Active Comparator

Tislelizumab combined with oxaliplatin and capecitabine tablets, 21days as a treatment cycle.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 106 locations

Suspended

Anhui Provincial Cancer Hospital

Hefei, ChinaOpen Anhui Provincial Cancer Hospital in Google Maps

Suspended

Anhui Provincial Cancer Hospital

Hefei, China

Suspended

Anhui Provincial Hospital (The First Affiliated Hospital of China University of Science and Technology)

Hefei, China

Suspended

The Second Hospital Of Anhui Medical University

Hefei, China

Recruiting soon106 Study Centers