Actively Recruiting
Phase II RAINSPOT: Zolbetuximab-Paclitaxel-Ramucirumab for CLDN18.2 Positive Gastro-esophageal Cancer
Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2025-12-22
100
Participants Needed
6
Research Sites
246 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Phase II RAINSPOT: Zolbetuximab-Paclitaxel-Ramucirumab for CLDN18.2 Positive Gastro-esophageal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 18 years of age at the time of informed consent
- WHO performance status 0 to 1
- Histologically confirmed metastatic gastroesophageal adenocarcinoma
- Prior treatment with one first-line therapy according to standard of care, with or without immunotherapy
- If relapse occurred during or within 6 months after adjuvant therapy, this counts as first-line treatment
- Tumor is CLDN18.2-positive with at least 75% of tumor cells showing moderate-to-strong staining by immunohistochemistry
- Any PDL1 expression score
- Use of highly effective birth control methods
- Voluntary written informed consent obtained prior to screening
You will not qualify if you...
- Metastatic squamous cell cancer of the esophagus
- Absolute contraindications for anti-VEGF inhibitors (such as tumor perforation, active proteinuria, recent stroke, heart attack, arterial thrombosis, or active wound problems)
- Presence of another active malignancy
- Prior treatment with Zolbetuximab or other anti-CLDN18.2 therapies in the first-line setting
- Known allergy to Zolbetuximab or any excipients (arginine, phosphoric acid, sucrose, polysorbate 80)
- Female who is pregnant, breastfeeding, or of child-bearing potential not using adequate contraception
- Participation in another interventional trial involving investigational drugs or devices
AI-Screening
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Trial Site Locations
Total: 6 locations
1
UZA
Antwerp, Belgium
Not Yet Recruiting
2
Cliniques Universitaires Saint-Luc Brussels
Brussels, Belgium
Not Yet Recruiting
3
HUB
Brussels, Belgium
Not Yet Recruiting
4
UZ Gent
Ghent, Belgium
Not Yet Recruiting
5
UZ Leuven
Leuven, Belgium, 3000
Actively Recruiting
6
AZ Delta Roeselare
Roeselare, Belgium
Not Yet Recruiting
Research Team
F
Filip Van Herpe, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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