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Phase II RAINSPOT: Zolbetuximab-Paclitaxel-Ramucirumab for CLDN18.2 Positive Gastro-esophageal Cancer

Study acronym: RAINSPOT
StatusRecruiting
PhasePhase 2
Started2025-12-11
View on ClinicalTrials.gov ↗

Amendment history

2025-12-15
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2029-10-01→2029-12-31
Start dateestimated 2025-10-01→confirmed 2025-12-11
Study sitesdetails revised at 6 of 6 sites
2025-05-05
minor
Original filing
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.
Trial Details
NCT Number NCT06962137
Lead Sponsor Universitaire Ziekenhuizen KU Leuven
Conditions Gastric Cancer Adenocarcinoma Metastatic, Gastric Adenocarcinoma and Gastroesophageal Junction Adenocarcinoma
Enrollment 100 participants
Start Date 2025-12-11
Primary Completion 2029-12-31 (estimated)
Study Completion 2030-08-30 (estimated)
Updated on ClinicalTrials.gov 2025-12-22