Locally Advanced or Metastatic GC and GCJ AdenocarcinomaPhase 3NCT07362186
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 study testing LM-108 in combination with Toripalimab and Paclitaxel injection intravenous infusion in people with Locally Advanced or Metastatic GC and GCJ Adenocarcinoma, run by LaNova Medicines Limited at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced or Metastatic GC and GCJ Adenocarcinoma
- What is being tested?
- LM-108 in combination with Toripalimab and Paclitaxel injection intravenous infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 30 Apr 2026to 28 Sep 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality
Lin Shen, +86 13564682439, linshenpku@163.com
About this study
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
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.
- Being tested
- LM-108 in combination with Toripalimab, Paclitaxel injection intravenous infusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LM-108 in combination with ToripalimabDrug
LM-108 combined with Toripalimab administered intravenously on Day 1 every 3 weeks
Paclitaxel injection intravenous infusionDrug
Paclitaxel injection administered at a dose of 80 mg/m² on Day 1, 8, and 15 every 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| LM-108 in combination with Toripalimab | Experimental | Not described Receives: Drug: LM-108 in combination with Toripalimab |
| Paclitaxel injection intravenous infusion | Active comparator | Not described Receives: Drug: Paclitaxel injection intravenous infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival (OS)
OS was defined as the time from date of randomization until death from any cause
Measured: up to 42 months
Secondary outcomes (5)
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
Measured: 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).
Measured: 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.
Measured: 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.
Measured: From start of treatment to date of documented disease progression, up to approximately 42 months
Incidence of adverse events (AEs)
Measured: up to 42 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2026
- Study start30 Apr 2026
- Primary completion17 Aug 2028 (estimated)
- Study completion28 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced or Metastatic GC and GCJ AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by LaNova Medicines LimitedThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LaNova Medicines Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lin Shen, Principal investigator, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07362186
- Sponsor's protocol ID
- LM108-03-202
- Status last verified
- Jan 2026
- First submitted
- 7 Jan 2026
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07362186
- Acronym / sponsor ID
- LM108-03-202
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- LaNova Medicines LimitedIndustry (pharma, biotech, devices)
- Study start
- 30 Apr 2026 (actual)
- Primary completion
- 17 Aug 2028 (estimated)
- Study completion
- 28 Sep 2028 (estimated)
- First posted
- 23 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LM-108 in combination with ToripalimabLM-108 combined with Toripalimab administered intravenously on Day 1 every 3 weeks | Drug | LM-108 in combination with Toripalimab |
| Paclitaxel injection intravenous infusionPaclitaxel injection administered at a dose of 80 mg/m² on Day 1, 8, and 15 every 4 weeks | Drug | Paclitaxel injection intravenous infusion |
Primary outcome
Overall survival (OS)
Time frame: up to 42 months
OS was defined as the time from date of randomization until death from any cause
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
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Locally Advanced or Metastatic GC and GCJ Adenocarcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lin Shen principal investigator
Peking University Cancer Hospital & Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing LM-108 in combination with Toripalimab and Paclitaxel injection intravenous infusion in people with Locally Advanced or Metastatic GC and GCJ Adenocarcinoma, run by LaNova Medicines Limited at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mengmeng Liu (+86 13918118040, mengmengliu@lanovamed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (OS) (time frame: up to 42 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2026.