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.

ConditionsLocally Advanced Unresectable or Metastatic Gastric Cancer Locally Advanced Unresectable or Metastatic Gastroesophageal Junction (GEJ) Adenocarcinoma

Trial statusRecruiting

Trial phasePhase 3

Trial typeInterventional

Biological sexAll

Age18-75

SponsorFutureGen Biopharmaceutical (Beijing) Co., Ltd

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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.

Trial design

Treatments tested in this trial

M108 monoclonal antibody
Placebo
Oxaliplatin
Capecitabine

Treatment groups

486 Participants

are divided into 2 treatment groups

Sponsors and collaborators

FutureGen Biopharmaceutical (Beijing) Co., Ltd

Lead sponsor

Source ClinicalTrials.gov