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

Официальное название

Phase II RAINSPOT: a Multicentric Open Label Trial of Zolbetuximab-Paclitaxel-Ramucirumab in Second Line Setting for CLDN18.2 Positive Gastro-esophageal Adenocarcinoma

Обзор

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.

Вмешательства

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

Первичные конечные точки

• OS (overall survival) [Срок оценки: From enrollment to the last FU visit of the patient (2 years)]

Вторичные конечные точки (2)

• PFS (progression free survival) [Срок оценки: From enrollment till last FU visit of patient (2 years). Data will be reported at the final study report (max 3 years from study start).]]
• Safety analysis [Срок оценки: Up to 90 days after last Zolbetuximab dose for each individual patient]

Критерии участия

Критерии включения

• At least 18 years of age at the time of ICF
• WHO performance status 0 - 1
• Histologically proven metastatic gastroesophageal adenocarcinoma
• Pretreatment with one 1st line therapy according to SOC (+/- immunotherapy)
• If relapse while adjuvant (immune/chemo) therapy or within 6 months ending adjuvant therapy the adjuvant therapy is considered a first line therapy
• CLDN18.2-positive (defined as ≥75% of tumour cells showing moderate-to-strong membranous CLDN18.2 staining, as determined by immunohistochemistry using the VENTANA CLDN18 \[43-14A\] RxDx Assay.
• Any PDL1 score
• Use of highly effective methods of birth control
• Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures.

Критерии исключения

\- 1. Metastatic squamous cell cancer of the esophagus 2. Absolute contra-indication for anti-VEGF inhibitors (tumor perforation, active proteinuria, recent stroke, myocardial infarction, acute arterial thrombosis, active wound problem) 3. Other active malignancy 4. Pretreatment with Zolbetuximab or other anti-CLDN18.2 direct therapy in first line setting once available.

5\. Known hypersensitivity to the active substance Zolbetuximab or to any of the excipients \[(Arginine, Phosphoric acid (E 338), Sucrose, Polysorbate 80 (E 433)\] 6. Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate, highly effective contraceptive 7. Participation in another interventional Trial with an investigational medicinal product (IMP) or device

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Бельгия · 6 центров

• UZA — Antwerp
• Cliniques Universitaires Saint-Luc Brussels — Brussels
• HUB — Brussels
• UZ Gent — Ghent
• UZ Leuven — Leuven
• AZ Delta Roeselare — Roeselare

Идентификаторы

NCT: NCT06962137 · S70358 · ISR007148 · 2025-521358-41-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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