RecruitingPhase 2NCT06962137

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


Sponsor

Universitaire Ziekenhuizen KU Leuven

Enrollment

100 participants

Start Date

Dec 11, 2025

Study Type

INTERVENTIONAL

Conditions

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 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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study (called RAINSPOT) is testing a three-drug combination — zolbetuximab, paclitaxel, and ramucirumab — for people with stomach or esophageal cancer (gastroesophageal adenocarcinoma) that has spread and come back after one prior treatment. Zolbetuximab is a targeted antibody that works on cancers with a specific protein called CLDN18.2. This is a phase 2 trial. **You may be eligible if...** - You are 18 or older - You have confirmed metastatic stomach or gastroesophageal junction cancer (adenocarcinoma) - Your cancer tests positive for the CLDN18.2 protein (at least 75% of tumor cells show moderate to strong expression) - You have already received one prior standard treatment (chemotherapy with or without immunotherapy) - You are in good general health (performance status 0–1) - You are willing to use effective birth control **You may NOT be eligible if...** - You have squamous cell cancer of the esophagus (this is a different cancer type) - You have contraindications to anti-VEGF drugs (like recent stroke, bleeding, or tumor perforation) - You have another active cancer - You have previously received zolbetuximab or another CLDN18.2-targeted therapy - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGzolbetuximab

The investigational product, Zolbetuximab, is a sterile lyophilized powder preparation with the chimeric monoclonal antibody Zolbetuximab as the active pharmaceutical ingredient.

OTHERRetrospective cohort, no intervention

No intervention


Locations(6)

UZA

Antwerp, Belgium

Cliniques Universitaires Saint-Luc Brussels

Brussels, Belgium

HUB

Brussels, Belgium

UZ Gent

Ghent, Belgium

UZ Leuven

Leuven, Belgium

AZ Delta Roeselare

Roeselare, Belgium

View Full Details on ClinicalTrials.gov

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NCT06962137


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