Status:
RECRUITING
Phase II RAINSPOT: Zolbetuximab-Paclitaxel-Ramucirumab for CLDN18.2 Positive Gastro-esophageal Cancer
Lead Sponsor:
Universitaire Ziekenhuizen KU Leuven
Conditions:
Gastric Cancer Adenocarcinoma Metastatic
Gastric Adenocarcinoma and Gastroesophageal Junction Adenocarcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study examines whether adding the drug Zolbetuximab to an existing treatment (Paclitaxel and Ramucirumab) can improve patients' survival. The goal is to see if this combination works better for p...
Eligibility Criteria
Inclusion
- At least 18 years of age at the time of ICF
- WHO performance status 0 - 1
- Histologically proven metastatic gastroesophageal adenocarcinoma
- Pretreatment with one 1st line therapy according to SOC (+/- immunotherapy)
- If relapse while adjuvant (immune/chemo) therapy or within 6 months ending adjuvant therapy the adjuvant therapy is considered a first line therapy
- 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.
- Any PDL1 score
- Use of highly effective methods of birth control
- Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures.
Exclusion
- \- 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
Key Trial Info
Start Date :
December 11 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 30 2030
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06962137
Start Date
December 11 2025
End Date
August 30 2030
Last Update
December 22 2025
Active Locations (6)
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1
UZA
Antwerp, Belgium
2
Cliniques Universitaires Saint-Luc Brussels
Brussels, Belgium
3
HUB
Brussels, Belgium
4
UZ Gent
Ghent, Belgium