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LM-302 and Gemcitabine for CLDN 18.2 Positive Pancreatic Cancer

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What is being tested

Gemcitabine

+ LM-302

Drug
Who is being recruted

Digestive System Diseases+5

+ Digestive System Neoplasms

+ Endocrine System Diseases

Over 18 Years
+47 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: August 2025
See protocol details

Summary

Principal SponsorShanghai Zhongshan Hospital
Study ContactWen-Quan Wang, Dr
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: August 10, 2025

Actual date on which the first participant was enrolled.

This clinical trial aims to test a new treatment combination for people with a specific type of advanced pancreatic cancer that cannot be removed by surgery. The study focuses on patients whose cancer is positive for a protein called CLDN 18.2 and who have not responded to their first line of treatment. Researchers are looking to see if a combination of two drugs, LM-302 and gemcitabine, can improve patient outcomes compared to past results. Finding an effective second-line treatment is important because options are limited for these patients, and this study could lead to better management of the disease. Participants in the study receive two drugs intravenously, meaning they are delivered directly into a vein. Gemcitabine is given on specific days within a four-week period, while LM-302 is administered every two weeks. Throughout the study, participants undergo regular imaging tests like CT or MRI scans to monitor the tumor's response to treatment. They also have safety assessments and provide blood samples to understand how the drugs affect the body and identify any side effects. This information helps researchers determine if the treatment is both effective and safe for patients.

Official TitleAn Open-label, Phase II Clinical Study to Evaluate the Efficacy and Safety of LM-302 Combined With Gemcitabine as Second-line Treatment for CLDN 18.2 Positive Unresectable Locally Advanced or Metastatic Pancreatic Cancer
NCT07108504
Principal SponsorShanghai Zhongshan Hospital
Study ContactWen-Quan Wang, Dr
Last updated: January 28, 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

30 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

Digestive System DiseasesDigestive System NeoplasmsEndocrine System DiseasesEndocrine Gland NeoplasmsNeoplasmsNeoplasms by SitePancreatic DiseasesPancreatic Neoplasms

Criteria

11 inclusion criteria required to participate
Capable of providing written informed consent, understanding and complying with study requirements. Willing to participate after full disclosure of the study's purpose, procedures, potential risks, and benefits, and must sign the informed consent form before any study-related procedures.
Age ≥18 years old.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, with no deterioration within 2 weeks before the first dose.
Expected survival ≥3 months.
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36 exclusion criteria prevent from participating
Previous treatment with gemcitabine or nab-paclitaxel.
Received any investigational drug or therapy within 28 days before the first dose of the study drug.
Recent Anticancer Therapy (within 21 days before the first dose, except for): Palliative radiotherapy (e.g., for bone metastasis pain control) within 14 days. Oral drugs (e.g., fluoropyrimidines, small-molecule targeted agents) within 14 days or 5 half-lives (whichever is longer). Traditional Chinese medicine with anticancer indications within 14 days. Nitrosoureas or mitomycin C within 42 days. Therapeutic radiopharmaceuticals within 56 days.
Residual Toxicities from Prior Therapy Adverse reactions from prior anticancer therapy have not recovered to CTCAE v5.0 Grade ≤1 (except for non-safety risks, such as alopecia, chronic radiotherapy toxicities ≤Grade 2, or lymphopenia).
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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

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental

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.
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