Locally Advanced Unresectable or Metastatic Gastric CancerPhase 3NCT06177041
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.
A Phase 3 study testing M108 monoclonal antibody, Oxaliplatin and Capecitabine in people with Locally Advanced Unresectable or Metastatic Gastric Cancer and Locally Advanced Unresectable or Metastatic Gastroesophageal Junction (GEJ) Adenocarcinoma, run by FutureGen Biopharmaceutical (Beijing) Co., Ltd at 1 site in China.
Trial 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 advanced gastric cancer, and there is an urgent need to explore and develop new therapeutic targets and combination… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Locally Advanced Unresectable or Metastatic Gastric Cancer, Locally Advanced Unresectable or Metastatic Gastroesophageal Junction (GEJ) Adenocarcinoma
- What is being tested?
- M108 monoclonal antibody, Oxaliplatin and Capecitabine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 486 participants
- Where
- 1 siteChina
- Study dates
- 25 Dec 2023to 11 Apr 2027
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Lin Shen, PhD, 010-88196358, doctorshenlin@sina.cn
Lin Shen, PhD
About this study
Official title: A Phase 3, Multi-Center, Double-Blind, Randomized, Efficacy and Safety Study of M108 Monoclonal Antibody 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.
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.
Read the 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 first-line treatment for Claudin (CLDN) 18.2-Positive, HER2-Negative, PD-L1 CPS<5, locally advanced or metastatic gastric/GEJ adenocarcinoma. Patients will be randomized in a 1:1 ration to receive M108 monoclonal antibody plus chemotherapy or placebo plus chemotherapy.
- Conditions
- Locally Advanced Unresectable or Metastatic Gastric Cancer, Locally Advanced Unresectable or Metastatic Gastroesophageal Junction (GEJ) Adenocarcinoma
- Being tested
- M108 monoclonal antibody, Placebo, Oxaliplatin, Capecitabine
- Medical subject headings
- Stomach Neoplasms, Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
M108 monoclonal antibodyDrug
M108 monoclonal antibody will be administered as a minimum 2-hour IV infusion.
PlaceboDrug
Placebo will be administered as a minimum 2-hour IV infusion.
OxaliplatinDrug
Oxaliplatin will be administered as a 2-hour IV infusion.
CapecitabineDrug
Capecitabine will be administered orally twice daily (bid).
| Study group | Role | What they receive |
|---|---|---|
| M108 plus CAPOX | Experimental | Not described Receives: Drug: M108 monoclonal antibody; Drug: Oxaliplatin; Drug: Capecitabine |
| placebo plus CAPOX | Placebo comparator | Not described Receives: Drug: Placebo; Drug: Oxaliplatin; Drug: Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From date of randomization to the date of disease progression, death or end of study, assessed up to 24 months
Secondary outcomes (2)
Overall survival (OS)
Compare OS (Based on RECIST 1.1 by IRC) of patients treated with M108 monoclonal antibody or placebo plus CAPOX.
Measured: From date of randomization to the date of death or end of study, assessed up to 24 months
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.
Measured: From date of randomization until 28+7 days after the last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2023
- Study start25 Dec 2023
- Primary completion11 Jan 2027 (estimated)
- Study completion11 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Unresectable or Metastatic Gastric CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 486 participants (estimated)
Sponsor and investigators
- Lead sponsor
- FutureGen Biopharmaceutical (Beijing) Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06177041
- Sponsor's protocol ID
- FG-M108-04
- Status last verified
- Feb 2024
- First submitted
- 11 Dec 2023
- Last updated
- 28 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No