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.

NCT06177041 | Recruiting Phase 3

• 1 other identifier: FG-M108-04
• Study Type: interventional
• Target: 486
• Locations: 1 country
• Sites: 1

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 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

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

Outcome Measures

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.

  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)

  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)

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

Study Arms (2)

M108 plus CAPOX

EXPERIMENTAL

Drug: M108 monoclonal antibody; Drug: Oxaliplatin; Drug: Capecitabine

placebo plus CAPOX

PLACEBO COMPARATOR

Drug: Placebo; Drug: Oxaliplatin; Drug: Capecitabine

Interventions

M108 monoclonal antibody DRUG

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

M108 plus CAPOX

Placebo DRUG

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

placebo plus CAPOX

Oxaliplatin DRUG

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

M108 plus CAPOX; placebo plus CAPOX

Capecitabine DRUG

Capecitabine will be administered orally twice daily (bid).

M108 plus CAPOX; placebo plus CAPOX

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• FutureGen Biopharmaceutical (Beijing) Co., Ltd: lead

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms; Adenocarcinoma

Interventions

Oxaliplatin; Capecitabine

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Central Study Contacts

Zhaoyu Jin, Ph.D

CONTACT

010-60709130; pr@futuregenbiopharm.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2023
• First Posted: December 20, 2023
• Study Start: December 25, 2023
• Primary Completion (Estimated): January 11, 2027
• Study Completion (Estimated): April 11, 2027
• Last Updated: February 28, 2024

Record last verified: 2024-02

Locations

CN (1)