Health TrialsbyHealthPanel

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 CancerLocally 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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • M108 monoclonal antibody

    Drug

    M108 monoclonal antibody will be administered as a minimum 2-hour IV infusion.

  • Placebo

    Drug

    Placebo will be administered as a minimum 2-hour IV infusion.

  • Oxaliplatin

    Drug

    Oxaliplatin will be administered as a 2-hour IV infusion.

  • Capecitabine

    Drug

    Capecitabine will be administered orally twice daily (bid).

Treatment groups

486 Participants
are divided into 2 treatment groups
Group A: M108 plus CAPOXExperimental treatment 3 interventions
Group B: placebo plus CAPOXPlacebo comparator 3 interventions

Trial outcomes

Primary outcomes

1

Progression free survival (PFS)

Compare PFS (Based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 by Independent Review Committee (IRC)) of patients treated with M108 monoclonal antibody or placebo plus CAPOX.

Time frame
From date of randomization to the date of disease progression, death or end of study, assessed up to 24 months

Secondary outcomes

1

Overall survival (OS)

Compare OS (Based on RECIST 1.1 by IRC) of patients treated with M108 monoclonal antibody or placebo plus CAPOX.

Time frame
From date of randomization to the date of death or end of study, assessed up to 24 months
2

Safety and tolerability assessed by adverse events (AEs)

An AE is any adverse medical event that occurs during a clinical study, whether or not related with medicinal product, including signs, symptoms, abnormal laboratory test results and diseases. The incidence and severity of AEs during the clinical study are recorded and analyzed.

Time frame
From date of randomization until 28+7 days after the last dose

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

FutureGen Biopharmaceutical (Beijing) Co., Ltd

Lead sponsor

Source ClinicalTrials.gov
Apply now