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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Locally Advanced or Metastatic GC and GCJ Adenocarcinoma
• Intervention / Treatment: Drug: LM-108 in combination with Toripalimab; Drug: Paclitaxel injection intravenous infusion

• Study Type: Interventional
• Enrollment (Estimated): 400
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Mengmeng Liu; Phone Number: +86 13918118040; Email: mengmengliu@lanovamed.com
• Study Contact Backup: Name: Paul Kong; Phone Number: +86 13564682439; Email: paulkong@lanovamed.com

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China
      • Recruiting
      • Beijing Cancer Hospital
      • Contact: Lin Shen; Phone Number: +86 13564682439; Email: linshenpku@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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:

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LM-108 in combination with Toripalimab	Drug: LM-108 in combination with Toripalimab; LM-108 combined with Toripalimab administered intravenously on Day 1 every 3 weeks
Active Comparator: Paclitaxel injection intravenous infusion	Drug: Paclitaxel injection intravenous infusion; Paclitaxel injection administered at a dose of 80 mg/m² on Day 1, 8, and 15 every 4 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival (OS)	OS was defined as the time from date of randomization until death from any cause	up to 42 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	up to 42 months
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).	up to 42 months
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 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)	defined as the proportion of participants who achieved CR, PR, or stable disease (SD) , based on Investigator assessment.	From start of treatment to date of documented disease progression, up to approximately 42 months
Incidence of adverse events (AEs)		up to 42 months

Collaborators and Investigators

• Sponsor: LaNova Medicines Limited
• Investigators: Principal Investigator: Lin Shen, Peking University Cancer Hospital & Institute

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2026
• Primary Completion (Estimated): August 17, 2028
• Study Completion (Estimated): September 28, 2028

Study Registration Dates

• First Submitted: January 7, 2026
• First Submitted That Met QC Criteria: January 15, 2026
• First Posted (Actual): January 23, 2026

Study Record Updates

• Last Update Posted (Actual): May 11, 2026
• Last Update Submitted That Met QC Criteria: May 6, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: toripalimab
• Other Study ID Numbers: LM108-03-202

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No