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

NCT07108504 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-08-07

No results posted yet for this study

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

Interventions

DRUG

Gemcitabine

Gemcitabine, 1000 mg/m², d1, 8, 15, q4 week

DRUG

LM-302

LM-302, 1.8 mg/kg, d1, q2 week

Sponsors & Collaborators

  • Shanghai Zhongshan Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-10
Primary Completion
2026-08-10
Completion
2028-08-10

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07108504 on ClinicalTrials.gov