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.
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.
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).
Single group
Gemcitabine
DrugGemcitabine, 1000 mg/m², d1, 8, 15, q4 week
LM-302
DrugLM-302, 1.8 mg/kg, d1, q2 week
Objective Response Rate (ORR) per RECIST 1.1
The proportion of participants with CLDN18.2-positive unresectable locally advanced or metastatic pancreatic adenocarcinoma achieving a best overall response of complete response (CR) or partial response (PR) as assessed by the investigator according to RECIST 1.1 criteria.
Duration of Response (DOR) per RECIST 1.1
The time from first documented objective response (CR or PR) until disease progression or death, whichever occurs first, as assessed by RECIST 1.1.
Disease Control Rate (DCR) per RECIST 1.1
The proportion of participants achieving CR, PR, or stable disease (SD) lasting ≥16 weeks, as assessed by RECIST 1.1.
Progression-Free Survival (PFS) per RECIST 1.1
Progression-Free Survival (PFS) is defined as the time from the first dose of study treatment (LM-302 + Gemcitabine) to the first occurrence of disease progression (per RECIST 1.1) or death from any cause, whichever occurs first.
Overall Survival (OS)
Overall Survival (OS) is defined as the time from the first dose of study treatment (LM-302 + Gemcitabine) to death from any cause.
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