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Recruiting NCT07362186

LM-108 in Combination With Toripalimab Versus Paclitaxel Injection for the Treatment of Subjects With CCR8-Positive Gastric and Gastroesophageal Junction Adenocarcinoma

Phase III Interventional Locally Advanced or Metastatic GC and GCJ Adenocarcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: LM-108 in combination with Toripalimab, Paclitaxel injection intravenous infusion.
Who it may be relevant to
Registry conditions: Locally Advanced or Metastatic GC and GCJ Adenocarcinoma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase III, Open-Label, Multicenter, Randomized, Parallel-Group Study to Evaluate the Efficacy and Safety of LM-108 in Combination With Toripalimab Versus Paclitaxel Injection as Second-Line Therapy for CCR8-Positive Locally Advanced or Metastatic Gastric Cancer/Gastroesophageal Junction Adenocarcinoma

Overview

This is a phase III， Multicenter, Randomized study， evaluating the efficacy and Safety of LM-108(an Anti-CCR8 mAb) in combination With Toripalimab Versus Paclitaxel Injection in subjects with CCR8-Positive locally advanced or metastatic Gastric Cancer and Gastroesophageal Junction Adenocarcinoma.

Interventions

  • Drug LM-108 in combination with Toripalimab
    LM-108 combined with Toripalimab administered intravenously on Day 1 every 3 weeks
  • Drug Paclitaxel injection intravenous infusion
    Paclitaxel injection administered at a dose of 80 mg/m² on Day 1, 8, and 15 every 4 weeks

Primary outcome measures

  • Overall survival (OS) [Time frame: up to 42 months]
Secondary outcome measures (5)
  • Progression Free Survival (PFS) [Time frame: up to 42 months]
  • Objective response rate (ORR) [Time frame: up to 42 months]
  • Duration of response (DOR) [Time frame: Time from initial response (CR or PR) to date of documented disease progression or death (due to any cause) whichever occurs first, up to 42 months]
  • Disease control rate (DCR) [Time frame: From start of treatment to date of documented disease progression, up to approximately 42 months]
  • Incidence of adverse events (AEs) [Time frame: up to 42 months]

Eligibility criteria

Inclusion criteria

  • Individuals who are willing to participate in the study and sign the informed consent form (ICF) prior to any procedure.
  • Age 18 years or older, male or female.
  • Weight ≥ 40 kg or Body Mass Index (BMI)≥ 18.5 kg/m²
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
  • Life expectancy ≥ 3 months.
  • Individuals must have histologically or cytologically confirmed locally advanced or metastatic gastric/gastroesophageal junction adenocarcinoma and be ineligible for curative surgery or radiotherapy.
  • Confirmed CCR8-positive by the central laboratory.
  • HER2-negative, low-expressing, or non-expressing.
  • Individuals must experience radiographic progression during or after prior standard first-line therapy, or who developed intolerance to treatment due to chemotherapy-related toxicity
  • At least one lesion.
  • Have appropriate organ and marrow function in laboratory examinations.
  • Women of childbearing potential have a negative pregnancy test and must not be breastfeeding. All of reproductive potential agree to use effective contraception throughout the study period and for 6 months after the last dose of study drug.

Exclusion criteria

  • Received treatment targeting the same target or other drugs acting on regulatory T cells (Tregs).
  • Received antitumor treatments such as chemotherapy, radiotherapy, biological therapy, immunotherapy, or Chinese herbal medicine or Chinese herbal preparations within 2-4 weeks (depending on the specific anticancer drug) prior to the first dose.
  • Received anti-PD-(L)1 antibody immunotherapy and experienced disease progression confirmed by RECIST 1.1 assessment within ≤2 months after treatment initiation.
  • Use of any live vaccine within 4 weeks prior to the first dosing of study drugs.
  • Individuals who received major surgery or interventional treatment within 4 weeks prior to the first dosing of study drugs.
  • Individuals who take systemic corticosteroids (> 10 mg daily prednisone equivalents) or other systemic immunosuppressive medications within 2 weeks prior to the first dosing of study drugs.
  • Any adverse event from prior anti-tumor therapy has not yet recovered to ≤ grade 1 of CTCAE v6.0, individuals who experienced ≥ Grade 3 immune-related adverse events during prior immunotherapy, or terminated prior immunotherapy due to severe or life-threatening immune-related adverse events.
  • Any other pathological type.
  • Uncontrollable clinical third-space fluid accumulation.
  • Unstable or progressive central nervous system (CNS) metastases or carcinomatous meningitis (meningeal metastases).
  • Individuals with a known history of autoimmune diseases.
  • For individuals with drug allergies or contraindications.
  • The investigator determined that there are other situations that are not suitable for participation in this study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Beijing Cancer Hospital — Beijing

Identifiers

NCT: NCT07362186 · LM108-03-202

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗