Last updated: February 25, 2024
Sponsor: FutureGen Biopharmaceutical (Beijing) Co., Ltd
Overall Status: Active - Recruiting
Phase
3
Condition
Adenocarcinoma
Treatment
Capecitabine
Placebo
Oxaliplatin
Clinical Study ID
NCT06177041
FG-M108-04
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Written informed consent
- Histologically confirmed diagnosis of locally advanced unresectable or metastaticgastric/GEJ adenocarcinoma with no treatment previously. For patients withneoadjuvant/adjuant chemotherapy in the past, duration of last therapy to recurrenceshould 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 thetime they sign their informed consent until 3 months after the last dosing. Femalesubjects of childbearing age must have a negative blood beta-HCG test within 72 hoursprior to first dosing.
Exclusion
Exclusion Criteria:
- Previous radiotherapy within 4 weeks prior to the start of study treatment. (ifpalliative radiotherapy was given to bone metastases and the patient recovered fromacute 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 M108monoclonal antibodies or other monoclonal antibodies (including humanized or chimericantibodies); Allergic or intolerant to any component of capecitabine, oxaliplatin,etc.
- Subject who has been treated with CLDN18.2 monoclonal/bispecific antibodies, CLDN18.2CAR-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 safedelivery of treatment within this study.
Study Design
Total Participants: 486
Treatment Group(s): 4
Primary Treatment: Capecitabine
Phase: 3
Study Start date:
December 25, 2023
Estimated Completion Date:
April 11, 2027
Study Description
Connect with a study center
Beijing Cancer Hospital
Beijing, Beijing 100142
ChinaActive - Recruiting
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