RecruitingPhase 2NCT05934331

A LM-302 Combination With Other Anti-Tumor Therapies Phase ll Study

An Open-label, Multicenter Phase II Clinical Study to Evaluate the Efficacy, Safety, and Tolerability of the LM-302 Combination With Other Anti-tumor Treatment in Subjects With CLDN18.2-positive Advanced Gastro-Intestinal Cancer.


Sponsor

LaNova Medicines Zhejiang Co., Ltd.

Enrollment

276 participants

Start Date

Jul 27, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This study is to evaluate the efficacy of the LM-302 Combination With Other Therapies in patients with CLDN18.2-positive Advanced Digestive Tract Tumor.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a drug called LM-302 in combination with other cancer treatments for people with advanced stomach or gastrointestinal cancers that express a protein called CLDN18.2. The study is for patients whose cancer has not responded to standard first-line treatment. **You may be eligible if...** - You are aged 18–80 and in good general health (ECOG 0–1) - You have been diagnosed with an advanced gastrointestinal tumor (confirmed by biopsy) - Your cancer tests positive for CLDN18.2 (a specific protein marker) - Your first-line treatment has failed or you could not tolerate it - You have at least one measurable tumor lesion - Your organs (liver, kidneys, blood counts) are functioning adequately - You have a life expectancy of at least 3 months **You may NOT be eligible if...** - Your cancer does not express CLDN18.2 - You have not yet received first-line treatment (except in specific circumstances) - Your organ function does not meet study requirements Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLM-302

Q2W/Q3W,Administered intravenously

DRUGToripalimab

Q2W/Q3W,Administered intravenously

DRUGCapecitabine

BID,Oral Administration

DRUGTegafur, Gimeracil and Oteracil Potassium Capsules

BID,Oral Administration

DRUGNivolumab

Q4W,Administered intravenously

DRUGApatinib

QD,Oral Administration

DRUGGemcitabine

Q4W,Administered intravenously


Locations(1)

Shanghai East Hospital

Shanghai, China

View Full Details on ClinicalTrials.gov

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NCT05934331