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Compares treatment options for Locally Advanced or Metastatic GC and GCJ Adenocarcinoma
Official title LM-108 in Combination With Toripalimab Versus Paclitaxel Injection for the Treatment of Subjects With CCR8-Positive Gastric and Gastroesophageal Junction Adenocarcinoma
ClinicalTrials.gov ID: NCT07362186
What this study is testing
What is LM-108 in combination with Toripalimab?
LM-108 in combination with Toripalimab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for locally advanced or metastatic gc and gcj adenocarcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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.
You likely can't join 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...
- Received anti-PD-(L)1 antibody immunotherapy and experienced disease progression confirmed by RECIST 1.1 assessment within ≤2 months after treatment...
- Use of any live vaccine within 4 weeks prior to the first dosing of study drugs.
- Individuals who received major surgery or treatment 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...
See the full eligibility criteria
- 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...
- 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)...
- 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 treatment 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.