Actively Recruiting
Phase II RAINSPOT: Zolbetuximab-Paclitaxel-Ramucirumab for CLDN18.2 Positive Gastro-esophageal Adenocarcinoma in Second Line Treatment
Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2025-12-22
100
Participants Needed
6
Research Sites
34 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether adding the drug Zolbetuximab to the standard treatment of Paclitaxel and Ramucirumab can improve survival for adults with metastatic gastroesophageal adenocarcinoma whose tumors express the protein CLDN18.2. This Phase II open-label trial compares this combination against historical data from patients who received only the standard drugs. The study is sponsored by Universitaire Ziekenhuizen KU Leuven and aims to explore potential benefits for this specific patient group. Participants in the study will receive Zolbetuximab by intravenous infusion with a loading dose of 800 mg/m² on the first day, followed by 400 mg/m² every two weeks. Paclitaxel will be given weekly at 80 mg/m² for three weeks, followed by a week off, and Ramucirumab will be administered at 8 mg/kg every two weeks. Treatment will continue as long as it is tolerated and the disease does not worsen. Additionally, patients may undergo a tumor biopsy if medically justified. A retrospective cohort will be identified from past patients treated with Paclitaxel and Ramucirumab without Zolbetuximab. During the study, participants will have regular hospital visits for treatment and monitoring. Researchers will assess overall survival over two years from enrollment, with secondary measures including progression-free survival and safety for up to 90 days after the last Zolbetuximab dose. The total study duration may span several years. Data collection will include clinical evaluations and follow-up visits to monitor the course of disease and treatment effects.
CONDITIONS
Brief 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 of 0 or 1
- Histologically confirmed metastatic gastroesophageal adenocarcinoma
- Previously treated with one first-line standard therapy, with or without immunotherapy
- Adjuvant therapy relapse within 6 months counts as first-line treatment
- Tumor positive for CLDN18.2 in at least 75% of cells by immunohistochemistry
- Any PD-L1 score
- Use of effective birth control methods
- Voluntary written informed consent obtained
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
- Previous treatment with Zolbetuximab or other anti-CLDN18.2 therapy in first-line setting
- Known allergy to Zolbetuximab or its ingredients (Arginine, Phosphoric acid, Sucrose, Polysorbate 80)
- Pregnancy, breastfeeding, or intention to become pregnant without effective contraception
- Participation in another interventional trial with investigational drugs or devices currently ongoing
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Treatment continues with doses every 2 weeks for Zolbetuximab and weekly doses of Paclitaxel for 3 weeks followed by a week break, according to routine practice.
Participants receive Zolbetuximab in combination with Paclitaxel and Ramucirumab as part of the treatment for gastro-esophageal cancer.
Weekly visits for Paclitaxel and biweekly visits for Zolbetuximab and Ramucirumab
Duration - Up to 90 days after last Zolbetuximab dose
Participants are monitored for safety for up to 90 days after the last Zolbetuximab dose.
1 to 2 visits during safety monitoring
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
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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