NCT07108504

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

An 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

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Shanghai Zhongshan Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Pancreatic Cancer
• Chemotherapy Effect

Interventions

Type	Name	Description
DRUG	Gemcitabine	Gemcitabine, 1000 mg/m², d1, 8, 15, q4 week
DRUG	LM-302	LM-302, 1.8 mg/kg, d1, q2 week

Timeline

• Start date: 2025-08-10
• Primary completion: 2026-08-10
• Completion: 2028-08-10
• First posted: 2025-08-07
• Last updated: 2025-08-07