Zolbetuximab with paclitaxel and ramucirumab for CLDN18.2-positive stomach and gastro‑esophageal junction cancer

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 II trial gives zolbetuximab by IV together with standard paclitaxel and ramucirumab to adults with metastatic gastric or gastro‑esophageal junction adenocarcinoma who have already received one prior standard first‑line therapy. Patients must have tumors that are CLDN18.2‑positive by a specified immunohistochemistry assay and will undergo tumor biopsy and regular clinical and imaging follow‑up. Outcomes for the treated group will be compared to historical (retrospective) cohorts of patients who received paclitaxel and ramucirumab alone. Treatment is given at scheduled hospital visits and safety, response, and survival endpoints will be recorded.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. At least 18 years of age at the time of ICF
2. WHO performance status 0 - 1
3. Histologically proven metastatic gastroesophageal adenocarcinoma
4. Pretreatment with one 1st line therapy according to SOC (+/- immunotherapy)
5. If relapse while adjuvant (immune/chemo) therapy or within 6 months ending adjuvant therapy the adjuvant therapy is considered a first line therapy
6. CLDN18.2-positive (defined as ≥75% of tumour cells showing moderate-to-strong membranous CLDN18.2 staining, as determined by immunohistochemistry using the VENTANA CLDN18 \[43-14A\] RxDx Assay.
7. Any PDL1 score
8. Use of highly effective methods of birth control
9. Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures.

Exclusion Criteria:

\- 1. Metastatic squamous cell cancer of the esophagus 2. Absolute contra-indication for anti-VEGF inhibitors (tumor perforation, active proteinuria, recent stroke, myocardial infarction, acute arterial thrombosis, active wound problem) 3. Other active malignancy 4. Pretreatment with Zolbetuximab or other anti-CLDN18.2 direct therapy in first line setting once available.

5\. Known hypersensitivity to the active substance Zolbetuximab or to any of the excipients \[(Arginine, Phosphoric acid (E 338), Sucrose, Polysorbate 80 (E 433)\] 6. Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate, highly effective contraceptive 7. Participation in another interventional Trial with an investigational medicinal product (IMP) or device

Where it's running

• UZ Leuven
  Leuven, Belgium Recruiting
• Uza
  Antwerp, Belgium Not yet recruiting
• Cliniques Universitaires Saint-Luc Brussels
  Brussels, Belgium Not yet recruiting
• Hub
  Brussels, Belgium Not yet recruiting
• UZ Gent
  Ghent, Belgium Not yet recruiting
• AZ Delta Roeselare
  Roeselare, Belgium Not yet recruiting

Study contacts

• Principal investigator: Filip Van Herpe, MD — Universitaire Ziekenhuizen KU Leuven
• Study coordinator: Filip Van Herpe, MD
• Email: filip.vanherpe@uzleuven.be
• Phone: +32 16 34 42 18

Similar studies

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

• Zolbetuximab added to FLOT and durvalumab before surgery for CLDN18.2-positive gastric/GEJ cancer

  This study tests whether adding zolbetuximab to FLOT chemotherapy plus durvalumab can improve tumor response before surgery in adults with CLDN18.2-positive gastric or GEJ cancer.

  Recruiting Phase 2 National Cancer Center, Japan · Saitama and 3 other locations · NCT07872722

• Zolbetuximab with chemotherapy for HER2-negative, Claudin 18.2–positive metastatic gastric or gastroesophageal junction adenocarcinoma

  This project will try zolbetuximab together with FOLFOX or XELOX as first-line treatment for adults whose HER2-negative stomach or gastroesophageal junction cancers strongly express Claudin 18.2.

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• Fruquintinib plus nab‑paclitaxel with iparomlimab and tuvonralimab for people with advanced gastric or GEJ cancer after immunotherapy

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• SHR-1701 with chemotherapy for gastric/GEJ cancer with peritoneal spread

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• Testing BDC-4182 for advanced gastric and gastroesophageal cancer

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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.