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Compares treatment options for Locally Advanced Unresectable or Metastatic Gastric Cancer
Official title M108 Plus CAPOX Versus Placebo Plus CAPOX as First-line Treatment for Claudin (CLDN) 18.2-Positive, HER2-Negative, PD-L1 CPS<5, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma.
ClinicalTrials.gov ID: NCT06177041
What this study is testing
What is M108 monoclonal antibody?
M108 monoclonal antibody is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for locally advanced unresectable or metastatic gastric cancer.
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
- Gastric/GEJ adenocarcinoma, which is one of the major leading causes of cancer-related deaths worldwide, is a global challenge to human health. However, standard chemotherapy has limited efficacy in advanced gastric cancer, and there is an urgent need to explore and develop new therapeutic targets and combination therapy modalities.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Written informed consent
- Histologically confirmed diagnosis of locally advanced unresectable or metastatic gastric/GEJ adenocarcinoma with no treatment previously. For...
- At least 1 measurable site of the disease according to RECIST 1.1 criteria.
- Positive CDLN 18.2 expression
- Negative HER2 expression, PD-L1 CPS\<5
You likely can't join if
- Previous radiotherapy within 4 weeks prior to the start of study treatment. (if palliative radiotherapy was given to bone metastases and the patient...
- Previous anti-tumor therapy within 4 weeks prior to the start of study treatment.
- Previous major operation within 4 weeks prior to the start of study treatment.
- Have a prior severe allergic reaction or intolerance to known components of M108 monoclonal antibodies or other monoclonal antibodies (including...
- Subject who has been treated with CLDN18.2 monoclonal/bispecific antibodies, CLDN18.2 CAR-T, CLDN18.2 ADC and any therapies that target CLDN18.2.
- Subject who is in pregnant or in lactation period.
See the full eligibility criteria
- Written informed consent
- Histologically confirmed diagnosis of locally advanced unresectable or metastatic gastric/GEJ adenocarcinoma with no treatment previously. For patients with neoadjuvant/adjuant chemotherapy in the past, duration of last...
- At least 1 measurable site of the disease according to RECIST 1.1 criteria.
- Positive CDLN 18.2 expression
- Negative HER2 expression, PD-L1 CPS\<5
- ECOG performance status (PS) 0-1
- Life expectancy \> 3 months
- Age ≥ 18 years and ≤75 years
- Adequate haematological/ coagulation/ hepatic/ renal function
- Men and women of childbearing age should agree to use effective contraception from the time they sign their informed consent until 3 months after the last dosing. Female people of childbearing age must have a negative...
- Previous radiotherapy within 4 weeks prior to the start of study treatment. (if palliative radiotherapy was given to bone metastases and the patient recovered from acute toxicity was allowed).
- Previous anti-tumor therapy within 4 weeks prior to the start of study treatment.
- Previous major operation within 4 weeks prior to the start of study treatment.
- Have a prior severe allergic reaction or intolerance to known components of M108 monoclonal antibodies or other monoclonal antibodies (including humanized or chimeric antibodies); Allergic or intolerant to any component...
- Subject who has been treated with CLDN18.2 monoclonal/bispecific antibodies, CLDN18.2 CAR-T, CLDN18.2 ADC and any therapies that target CLDN18.2.
- Subject who is in pregnant or in lactation period.
- Other clinically significant disease which may have adversely affected the safe delivery of treatment within 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 to 75 years. 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.