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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-11

Study Completion Date

2030-08-30

Brief Summary

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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.

Detailed Description

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Conditions

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Gastric Cancer Adenocarcinoma Metastatic Gastric Adenocarcinoma and Gastroesophageal Junction Adenocarcinoma

Keywords

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Zolbetuximab-Paclitaxel-Ramucirumab second line CLDN18.2 positive gastro-esophageal adenocarcinoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

The Trial is divided into a prospective open label cohort and a retrospective cohort. There are six participating centers.

All patients with known CLDN18.2 positivity at baseline are eligible for the prospective cohort, if they did not receive anti-CLD18.2 therapy as first line therapy. It is acceptable to have the CLDN18.2 information tested during their 1st line therapy. All participants who will be included in the trial will remain on the trial until confirmation of disease progression.

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

zolbetuximab

Intervention Type DRUG

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

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.

Group Type OTHER

Retrospective cohort, no intervention

Intervention Type OTHER

No intervention

Interventions

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zolbetuximab

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

Intervention Type DRUG

Retrospective cohort, no intervention

No intervention

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. At least 18 years of age at the time of ICF
2. WHO performance status 0 - 1
3. Histologically proven metastatic gastroesophageal adenocarcinoma
4. Pretreatment with one 1st line therapy according to SOC (+/- immunotherapy)
5. If relapse while adjuvant (immune/chemo) therapy or within 6 months ending adjuvant therapy the adjuvant therapy is considered a first line therapy
6. 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.
7. Any PDL1 score
8. Use of highly effective methods of birth control
9. Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures.

Exclusion Criteria

\- 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Filip Van Herpe, MD

Role: PRINCIPAL_INVESTIGATOR

Universitaire Ziekenhuizen KU Leuven

Locations

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