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RecruitingNCT07362186Updated May 11, 2026

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

A Phase 3 interventional study of LM-108 in combination with Toripalimab and Paclitaxel injection intravenous infusion in Locally Advanced or Metastatic GC and GCJ Adenocarcinoma, sponsored by LaNova Medicines Limited. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-11.

Sponsored by LaNova Medicines Limited · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Started Apr 2026; still recruiting 5 months later.
Phase
Phase 3
Study type
Interventional
Enrollment
400
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Locally Advanced or Metastatic GC and GCJ Adenocarcinoma
03

In context

Lead sponsor

LaNova Medicines Limited is the lead sponsor of 18 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Individuals who are willing to participate in the study and sign the informed consent form (ICF) prior to any procedure.
  2. Age 18 years or older, male or female.
  3. Weight ≥ 40 kg or Body Mass Index (BMI)≥ 18.5 kg/m²
  4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
  5. Life expectancy ≥ 3 months.
  6. Individuals must have histologically or cytologically confirmed locally advanced or metastatic gastric/gastroesophageal junction adenocarcinoma and be ineligible for curative surgery or radiotherapy.
  7. Confirmed CCR8-positive by the central laboratory.
  8. HER2-negative, low-expressing, or non-expressing.
  9. Individuals must experience radiographic progression during or after prior standard first-line therapy, or who developed intolerance to treatment due to chemotherapy-related toxicity
  10. At least one lesion.
  11. Have appropriate organ and marrow function in laboratory examinations.
  12. 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

Exclusion Criteria:

  1. Received treatment targeting the same target or other drugs acting on regulatory T cells (Tregs).
  2. 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.
  3. Received anti-PD-(L)1 antibody immunotherapy and experienced disease progression confirmed by RECIST 1.1 assessment within ≤2 months after treatment initiation.
  4. Use of any live vaccine within 4 weeks prior to the first dosing of study drugs.
  5. Individuals who received major surgery or interventional treatment within 4 weeks prior to the first dosing of study drugs.
  6. 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.
  7. 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.
  8. Any other pathological type.
  9. Uncontrollable clinical third-space fluid accumulation.
  10. Unstable or progressive central nervous system (CNS) metastases or carcinomatous meningitis (meningeal metastases).
  11. Individuals with a known history of autoimmune diseases.
  12. For individuals with drug allergies or contraindications.
  13. The investigator determined that there are other situations that are not suitable for participation in this study.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
400 participants (estimated)

Study arms

  • Experimental
    LM-108 in combination with Toripalimab

    Drug: LM-108 in combination with Toripalimab

  • Active comparator
    Paclitaxel injection intravenous infusion

    Drug: Paclitaxel injection intravenous infusion

Interventions

  • DrugLM-108 in combination with Toripalimab

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

  • DrugPaclitaxel injection intravenous infusion

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

06

What researchers measure

Primary outcomes

  1. Overall survival (OS)

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

    Time frame: up to 42 months

Secondary outcomes

  1. Progression Free Survival (PFS)

    PFS was defined as the time from date of randomization until first objective radiographic tumor progression or death from any cause, based on Investigator assessment

    Time frame: up to 42 months

  2. Objective response rate (ORR)

    ORR is defined as the proportion of subjects achieving the best overall response (BOR) of CR or PR. BOR refers to the best response recorded during the period from the date of randomization to the date of objective progression documented according to RECIST 1.1 criteria or the date of initiation of subsequent antitumor therapy (whichever occurs first).

    Time frame: up to 42 months

  3. Duration of response (DOR)

    defined time from the initial response (CR or PR) until documented tumor progression or death from any cause and based on Investigator assessment.

    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

  4. Disease control rate (DCR)

    defined as the proportion of participants who achieved CR, PR, or stable disease (SD) , based on Investigator assessment.

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

  5. Incidence of adverse events (AEs)

    Time frame: up to 42 months

07

Study locations

1 of 1 sites recruiting
  • Beijing Cancer Hospital
    Beijing, Beijing Municipality, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07362186
Lead sponsor
LaNova Medicines Limited
Responsible party
Sponsor
First posted
Jan 23, 2026
Start date
Apr 30, 2026
Primary completion
Aug 17, 2028 (estimated)
Completion
Sep 28, 2028 (estimated)
Last update
May 11, 2026

Study contacts

Mengmeng Liu
Contact
mengmengliu@lanovamed.com
+86 13918118040
Paul Kong
Contact
paulkong@lanovamed.com
+86 13564682439
Lin Shen
principal investigator · Peking University Cancer Hospital & Institute

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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