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

NCT07362186 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: LM108-03-202
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

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

Locally Advanced or Metastatic GC and GCJ Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• Overall survival (OS)

  OS was defined as the time from date of randomization until death from any cause

  up to 42 months

Secondary Outcomes (5)

• Progression Free Survival (PFS)

  up to 42 months

• Objective response rate (ORR)

  up to 42 months

• Duration of response (DOR)

  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)

  From start of treatment to date of documented disease progression, up to approximately 42 months

• Incidence of adverse events (AEs)

  up to 42 months

Study Arms (2)

LM-108 in combination with Toripalimab

EXPERIMENTAL

Drug: LM-108 in combination with Toripalimab

Paclitaxel injection intravenous infusion

ACTIVE COMPARATOR

Drug: Paclitaxel injection intravenous infusion

Interventions

LM-108 in combination with Toripalimab DRUG

LM-108 combined with Toripalimab administered intravenously on Day 1 every 3 weeks

LM-108 in combination with Toripalimab

Paclitaxel injection intravenous infusion DRUG

Paclitaxel injection administered at a dose of 80 mg/m² on Day 1, 8, and 15 every 4 weeks

Paclitaxel injection intravenous infusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• LaNova Medicines Limited: lead

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Location

MeSH Terms

Interventions

toripalimab

Study Officials

• Lin Shen

  Peking University Cancer Hospital & Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mengmeng Liu

CONTACT

+86 13918118040; mengmengliu@lanovamed.com

Paul Kong

CONTACT

+86 13564682439; paulkong@lanovamed.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2026
• First Posted: January 23, 2026
• Study Start: April 3, 2026
• Primary Completion (Estimated): August 17, 2028
• Study Completion (Estimated): September 28, 2028
• Last Updated: January 23, 2026

Record last verified: 2026-01

Locations

CN (1)