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.

Launched by FUTUREGEN BIOPHARMACEUTICAL (BEIJING) CO., LTD · Dec 11, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment option for patients with advanced gastric cancer or gastroesophageal junction adenocarcinoma. Specifically, it is comparing a new drug called M108, which is a type of antibody, combined with standard chemotherapy (capecitabine and oxaliplatin, known as CAPOX) against a placebo (a treatment with no active drug) combined with the same chemotherapy. The main goal is to see if the M108 treatment helps patients live longer without their cancer getting worse.

To join the study, participants must be between 18 and 75 years old and have a confirmed diagnosis of advanced gastric or GEJ adenocarcinoma that has not been treated before. They should also have specific characteristics in their cancer cells, such as positive CDLN 18.2 expression, and not have certain other health issues that could complicate treatment. Participants will receive the assigned treatment and will be monitored for safety and potential side effects, as well as how the treatment affects their quality of life. Overall, this trial aims to find better treatment options for those facing this challenging disease.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Written informed consent
• • 2. 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 therapy to recurrence should be more than 6 months
• • 3. At least 1 measurable site of the disease according to RECIST 1.1 criteria.
• • 4. Positive CDLN 18.2 expression
• • 5. Negative HER2 expression, PD-L1 CPS\<5
• • 6. ECOG performance status (PS) 0-1
• • 7. Life expectancy \> 3 months
• • 8. Age ≥ 18 years and ≤75 years
• • 9. Adequate haematological/ coagulation/ hepatic/ renal function
• • 10. 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 subjects of childbearing age must have a negative blood beta-HCG test within 72 hours prior to first dosing.
• Exclusion Criteria:
• • 1. 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).
• • 2. Previous anti-tumor therapy within 4 weeks prior to the start of study treatment.
• • 3. Previous major operation within 4 weeks prior to the start of study treatment.
• • 4. 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 of capecitabine, oxaliplatin, etc.
• • 5. 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.
• • 6. Subject who is in pregnant or in lactation period.
• • 7. Other clinically significant disease which may have adversely affected the safe delivery of treatment within this study.