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Phase II RAINSPOT: a multicentric open label trial of Zolbetuximab-Paclitaxel-Ramucirumab in second line setting for CLDN18.2 positive gastro-esophageal adenocarcinoma
EU CTIS ID: 2025-521358-41-00
What this study is testing
To evaluate the effect of the addition of Zolbetuximab to standard treatment on survival in CLDN18.2 positive patients that were previously treated in first line but unexposed to Zolbetuximab or other anti CLDN18.2 targeted therapy.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- At least 18 years of age at the time of signing the Informed Consent Form (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.
You likely can't join if
- Metastatic squamous cell cancer of the esophagus
- Absolute contra-indication for anti-VEGF inhibitors (tumour perforation, active proteinuria, recent stroke, myocardial infarction, acute arterial thrombosis, active wound problem)
- Other active malignancy
- Pretreatment with Zolbetuximab or other anti-CLDN18.2 direct therapy in first line setting once available
- Known hypersensitivity to the active substance Zolbetuximab or to any of the excipients [(Arginine, Phosphoric acid (E 338), Sucrose, Polysorbate 80 (E 433)]
- 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
See the full eligibility criteria
- At least 18 years of age at the time of signing the Informed Consent Form (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; defined as those that, alone or in combination, result in low failure rate (i.e., less than 1% per year) when used consistently and correctly; such as implants, injectables, combined oral contraceptives, some IUDs, true sexual abstinence (i.e. refraining from heterosexual intercourse during the entire period of risk associated with the Trial treatment(s)) or commitment to a vasectomised partner.
- Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures.
- Metastatic squamous cell cancer of the esophagus
- Absolute contra-indication for anti-VEGF inhibitors (tumour perforation, active proteinuria, recent stroke, myocardial infarction, acute arterial thrombosis, active wound problem)
- Other active malignancy
- Pretreatment with Zolbetuximab or other anti-CLDN18.2 direct therapy in first line setting once available
- Known hypersensitivity to the active substance Zolbetuximab or to any of the excipients [(Arginine, Phosphoric acid (E 338), Sucrose, Polysorbate 80 (E 433)]
- 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
- Participation in another interventional Trial with an investigational medicinal product (IMP) or device
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.