Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT07362186

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

Led by LaNova Medicines Limited · Updated on 2026-05-11

400

Participants Needed

1

Research Sites

126 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Willing to participate and sign informed consent
  • Age 18 years or older, any gender
  • Weight at least 40 kg or BMI at least 18.5 kg/m²
  • ECOG performance status of 0 or 1
  • Life expectancy of at least 3 months
  • Histologically or cytologically confirmed locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma
  • Confirmed CCR8-positive status by central laboratory
  • HER2-negative, low-expressing, or non-expressing tumor
  • Experienced disease progression during or after prior standard first-line therapy or intolerance to chemotherapy due to toxicity
  • At least one measurable lesion
  • Adequate organ and marrow function based on lab tests
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during the study and for 6 months after last dose
Not Eligible

You will not qualify if you...

  • Received treatment targeting regulatory T cells or the same target molecule
  • Received chemotherapy, radiotherapy, biological therapy, immunotherapy, or Chinese herbal medicine within 2-4 weeks prior to first dose
  • Received anti-PD-(L)1 antibody immunotherapy with disease progression within 2 months after treatment start
  • Used any live vaccine within 4 weeks before first dose
  • Had major surgery or interventional treatment within 4 weeks before first dose
  • Taken systemic corticosteroids (>10 mg prednisone equivalent) or immunosuppressive drugs within 2 weeks before first dose
  • Have unresolved adverse events from prior antitumor therapy above grade 1 or severe immune-related adverse events
  • Have any other pathological cancer type
  • Have uncontrollable fluid accumulation in the body
  • Have unstable or progressing central nervous system metastases or carcinomatous meningitis
  • Have a known history of autoimmune disease
  • Have drug allergies or contraindications
  • Any other conditions deemed unsuitable by the investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Actively Recruiting

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Research Team

M

Mengmeng Liu

CONTACT

P

Paul Kong

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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