M108 plus chemotherapy for advanced gastric cancer treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 3, double-blind, randomized, placebo-controlled study aims to evaluate the efficacy and safety of the M108 monoclonal antibody combined with capecitabine and oxaliplatin (CAPOX) compared to a placebo plus CAPOX in patients with locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma. The study focuses on patients who are Claudin 18.2-positive, HER2-negative, and have a PD-L1 CPS of less than 5. Participants will be monitored for progression-free survival, safety, tolerability, pharmacokinetics, immunogenicity, and quality of life. The goal is to find a more effective first-line treatment option for this challenging cancer type.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Written informed consent
2. 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
3. At least 1 measurable site of the disease according to RECIST 1.1 criteria.
4. Positive CDLN 18.2 expression
5. Negative HER2 expression, PD-L1 CPS\<5
6. ECOG performance status (PS) 0-1
7. Life expectancy \> 3 months
8. Age ≥ 18 years and ≤75 years
9. Adequate haematological/ coagulation/ hepatic/ renal function
10. 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.

Exclusion Criteria:

1. 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).
2. Previous anti-tumor therapy within 4 weeks prior to the start of study treatment.
3. Previous major operation within 4 weeks prior to the start of study treatment.
4. 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.
5. 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.
6. Subject who is in pregnant or in lactation period.
7. Other clinically significant disease which may have adversely affected the safe delivery of treatment within this study.

Where it's running

• Beijing Cancer Hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Zhaoyu Jin, Ph.D
• Email: pr@futuregenbiopharm.com
• Phone: 010-60709130

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Long-term follow-up after cadonilimab (AK104) treatment

  This follow-up collects long-term health and survival information from people with advanced gastric cancer who previously received cadonilimab (AK104) in earlier clinical trials.

  Recruiting Akeso · Beijing · NCT07547787

• Observing the safety of VYLOY in patients with gastric or GEJ cancer in South Korea

  This study is testing how safe the drug VYLOY is for people in South Korea with advanced stomach or gastroesophageal junction cancer who are receiving it as part of their regular treatment.

  Recruiting at 15 sites Astellas Pharma Inc · Goyang-si, Gyeonggi-do and 14 other locations · NCT06902545

• Zolbetuximab plus pembrolizumab and chemotherapy for stomach and gastroesophageal junction cancer

  This trial will test whether adding zolbetuximab to pembrolizumab and standard chemotherapy helps adults with Claudin 18.2-positive, HER2-negative locally advanced or metastatic stomach or gastroesophageal junction cancer.

  Recruiting at 187 sites Phase 3 Astellas Pharma Inc · Birmingham, Alabama and 252 other locations · NCT06901531

• SKB264 with inetetamab for HER2-positive advanced breast cancer after progression on T-DXd

  This trial will see if combining SKB264 and inetetamab helps adults with HER2-positive unresectable or metastatic breast cancer whose disease progressed after trastuzumab deruxtecan (T-DXd).

  Recruiting Phase 2 Fudan University · Shanghai · NCT07182721

• Personalized vaccine combined with pembrolizumab for advanced solid tumors

  This study is testing a new personalized cancer vaccine combined with pembrolizumab to see if it helps people with advanced solid tumors fight their cancer better.

  Recruiting Phase 1/2 Mayo Clinic · Jacksonville, Florida · NCT05269381

• Test a combination of SSGJ-705 and SSGJ-612 (with or without chemotherapy) in advanced HER2-expressing solid cancers

  This phase 2 study tests whether SSGJ-705 plus SSGJ-612, with or without chemotherapy, can help adults with advanced HER2-expressing solid tumors like colorectal, urothelial, breast, gastric, or biliary cancers.

  Recruiting Phase 2 Shenyang Sunshine Pharmaceutical Co., LTD. · Hangzhou, Zhejiang · NCT07646626

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.