Status:
RECRUITING
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.
Lead Sponsor:
FutureGen Biopharmaceutical (Beijing) Co., Ltd
Conditions:
Locally Advanced Unresectable or Metastatic Gastric Cancer
Locally Advanced Unresectable or Metastatic Gastroesophageal Junction (GEJ) Adenocarcinoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
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 a...
Detailed Description
The aim of this phase 3, double-blind, randomized, placebo-controlled study is to explore the efficacy and safety of M108 monoclonal antibody plus chemotherapy versus placebo plus chemotherapy as firs...
Eligibility Criteria
Inclusion
- 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 therapy to recurrence should be more than 6 months
- 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 subjects of childbearing age must have a negative blood beta-HCG test within 72 hours prior to first dosing.
Exclusion
- 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 of capecitabine, oxaliplatin, etc.
- 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.
Key Trial Info
Start Date :
December 25 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 11 2027
Estimated Enrollment :
486 Patients enrolled
Trial Details
Trial ID
NCT06177041
Start Date
December 25 2023
End Date
April 11 2027
Last Update
February 28 2024
Active Locations (1)
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1
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100142