Efficacy and Safety of LM-302 Combined With Gemcitabine CLDN 18.2 Positive Unresectable Locally Advanced or Metastatic Pancreatic Cancer

The goal of this clinical trial is to evaluate the efficacy and safety of LM-302 combined with gemcitabine as a second-line treatment for CLDN 18.2-positive unresectable locally advanced or metastatic pancreatic cancer. The main questions it aim to answer: 1. Does LM-302 plus gemcitabine improve the objective response rate (ORR, per RECIST 1.1) compared to historical controls? 2. What is the safety and tolerability profile of this combination therapy? Participants will receive: 1. Gemcitabine (1000 mg/m² IV on Days 1, 8, and 15) in 4-week cycles, and LM-302 (1.8 mg/kg IV on Day 1) in 2-week cycles, 2. Undergo regular tumor imaging (CT/MRI) and safety assessments; 3. Provide blood samples for biomarker and pharmacokinetic analyses.

NCT Number	NCT07108504
Lead Sponsor	Shanghai Zhongshan Hospital
Conditions	Pancreatic Cancer, Chemotherapy Effect
Enrollment	30 participants
Start Date	2025-08-10
Primary Completion	2026-08-10 (estimated)
Study Completion	2028-08-10 (estimated)
Updated on ClinicalTrials.gov	2025-08-07