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

Sponsor
Universitaire Ziekenhuizen KU Leuven
Study ID
NCT06962137
Phase
PHASE2
Status
Recruiting
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Conditions

  • Gastric Adenocarcinoma and Gastroesophageal Junction Adenocarcinoma
  • Gastric Cancer Adenocarcinoma Metastatic

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • zolbetuximab — DRUG
    The investigational product, Zolbetuximab, is a sterile lyophilized powder preparation with the chimeric monoclonal antibody Zolbetuximab as the active pharmaceutical ingredient.
  • Retrospective cohort, no intervention — OTHER
    No intervention

Study Details

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.

Key Dates

Start date
Dec 11, 2025
Status verified
Dec 2025
Primary completion
Dec 31, 2029
Completion
Aug 30, 2030

Study Design

Enrollment
100 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Prospective cohort - Zolbetuximab + SOC Palcitaxel and Ramucirumab
    * Zolbetuximab: 800 mg/m² loading dose of at C1D1, followed by subsequent doses of 400 mg/m² every 2 weeks. Zolbetuximab should be administered after antiemetic premedication but prior to Paclitaxel-Ramucirumab. * Paclitaxel: 80 mg/m² weekly for 3 weeks followed by a week of break according to routine practice. * Ramucirumab: 8 mg/kg every 2 weeks according to routine practice.
  • Other: Retrospective cohort
    For the retrospective cohort the investigators will identify patients treated with Paclitaxel-Ramucirumab between January 2021 until December 2023 (the era of immunotherapy) in the forementioned centers that have confirmed CLDN18.2 positivity on a baseline biopsy but were not treated with Zolbetuximab in first line setting (nor in experimental setting). Treatment with immunotherapy or targeted therapy in first line setting is allowed.

Primary Outcome Measure

OS (overall survival) [ Time Frame: From enrollment to the last FU visit of the patient (2 years) ]

Central Contacts

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