NCT06962137RecruitingPhase 2
Phase II RAINSPOT: Zolbetuximab-Paclitaxel-Ramucirumab for CLDN18.2 Positive Gastro-esophageal Cancer
Phase II RAINSPOT: a Multicentric Open Label Trial of Zolbetuximab-Paclitaxel-Ramucirumab in Second Line Setting for CLDN18.2 Positive Gastro-esophageal Adenocarcinoma
Source: ClinicalTrials.gov · Last updated 22 Dec 2025
Brief summary (registry, in English)
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 patients whose tumours contain a specific protein (CLDN18.2). The results will be compared to past patient data from those who only received the standard treatment. Zolbetuximab (Vyloy) is a cancer medicine that is used to treat adults with gastric or gastro-esophageal junction adenocarcinoma (a type of cancer of the stomach or the transition between the stomach and esophagus). Zolbetuximab will be administered via an intravenous infusion in combination with Paclitaxel and Ramucirumab (Cyramza) (two other cancer drugs that are the standard treatment for this condition). Treatment will take place at regular intervals in the hospital. In addition to treatment,patients will undergo a tumour biopsy. While the biopsy procedure may cause some discomfort or pain, it will only be performed if medically justifiable. Patients participation in the study will continue as long as they receive treatment and the disease does not worsen. The overall duration of the study, for all patients, will span several years.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 24 Apr 2025
- Start date
- 11 Dec 2025
- Primary completion date
- 31 Dec 2029
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT06962137
- EU CT number
- 2025-521358-41-00
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 100
- From 11 Dec 2025 to the primary completion date, 31 Dec 2029
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- \- 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
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UZA Coordinator of this site? Confirm its status | Antwerp | Belgium | Not yet recruiting |
| Cliniques Universitaires Saint-Luc Brussels Coordinator of this site? Confirm its status | Brussels | Belgium | Not yet recruiting |
| HUB Coordinator of this site? Confirm its status | Brussels | Belgium | Not yet recruiting |
| UZ Gent Coordinator of this site? Confirm its status | Ghent | Belgium | Not yet recruiting |
| UZ Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Recruiting |
| AZ Delta Roeselare Coordinator of this site? Confirm its status | Roeselare | Belgium | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.