Actively 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.
Led by FutureGen Biopharmaceutical (Beijing) Co., Ltd · Updated on 2024-02-28
486
Participants Needed
1
Research Sites
171 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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. The main purpose of this study is to explore the efficacy of M108 monoclonal antibody plus capecitabine and oxaliplatin (CAPOX) versus placebo plus CAPOX as first-line treatment measured by progression free survival (PFS). This study will also evaluate safety, tolerability, pharmacokinetics and the immunogenicity profile of M108 monoclonal antibody, as well as its effects on quality of life.
CONDITIONS
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.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent
- Histologically confirmed locally advanced unresectable or metastatic gastric/GEJ adenocarcinoma with no prior treatment, or relapse more than 6 months after neoadjuvant/adjuvant chemotherapy
- At least one measurable disease site by RECIST 1.1 criteria
- Positive Claudin (CLDN) 18.2 expression
- Negative HER2 expression and PD-L1 CPS <5
- ECOG performance status of 0 or 1
- Life expectancy greater than 3 months
- Age between 18 and 75 years
- Adequate blood, coagulation, liver, and kidney function
- Agreement to use effective contraception during and for 3 months after treatment; females of childbearing age must have a negative pregnancy test within 72 hours before first dose
You will not qualify if you...
- Radiotherapy within 4 weeks before starting study treatment (except recovered palliative radiotherapy to bone metastases)
- Anti-tumor therapy within 4 weeks before starting study treatment
- Major surgery within 4 weeks before starting study treatment
- Severe allergic reaction or intolerance to M108 or other monoclonal antibodies, capecitabine, oxaliplatin, or related components
- Prior treatment with CLDN18.2-targeted therapies including monoclonal/bispecific antibodies, CAR-T, or ADC
- Pregnancy or breastfeeding
- Other significant diseases that could affect safe treatment delivery
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100142
Actively Recruiting
Research Team
Z
Zhaoyu Jin, Ph.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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