Evidence map›Paper›PMID 31240302›Full record

Trial reportAnnals of oncology : official journal of the European Society for Medical Oncology2019

A multicentre, phase IIa study of zolbetuximab as a single agent in patients with recurrent or refractory advanced adenocarcinoma of the stomach or lower oesophagus: the MONO study.

O Türeci, U Sahin, H Schulze-Bergkamen, Z Zvirbule, F Lordick, D Koeberle, P Thuss-Patience, T Ettrich, D Arnold, F Bassermann and 10 more

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Annals of oncology : official journal of the European Society for Medical Oncology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01197885 (International, Multicenter, Open-label, Phase II Study to Investigate the Efficacy and Safety of Multiple Doses of IMAB362 in Patients With Advanced Adenocarcinoma of the Stomach or the Lower Esophagus), which is not on this map. Cited by 155 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
155citing papers in PubMed, 4 pooled it
14.1field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01197885 phase2completednot on this map

International, Multicenter, Open-label, Phase II Study to Investigate the Efficacy and Safety of Multiple Doses of IMAB362 in Patients With Advanced Adenocarcinoma of the Stomach or the Lower Esophagus

TypeinterventionalSponsorGanymed Pharmaceuticals GmbHRan2010 to 2015Enrolled54ConditionsSolid TumorsArmsIMAB362
3 · Its place in the literature

Who cites it

155 citing papers in PubMed, 4 syntheses or guidelines pooled it, 238 citations in OpenAlex.

  1. Pooled it
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  4. The Significance of theFrontiers in oncology · 2020
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  11. Claudin 18.2 Targeting: A Pan-Cancer Perspective.Clinical cancer research : an official journal of the American Association for Cancer Research · 2026
    Review
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95 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

20 authors at 14 institutions in 4 countries.

O TüreciCi3 - Cluster of Individualized Immune Intervention, Mainz. Electronic address: tureci@uni-mainz.de.
U SahinTRON - Translational Oncology at the University Medical Center of the Johannes Gutenberg University Mainz, Mainz.
H Schulze-BergkamenNational Center for Tumor Diseases, Heidelberg University Hospital, Heidelberg, Germany.
Z ZvirbuleRiga East University Hospital, LLC, Riga, Latvia.
F LordickUniversity Cancer Center Leipzig, University Medicine Leipzig, Leipzig, Germany.
D KoeberleDepartment of Oncology and Hematology, Kantonsspital, St. Gallen, Switzerland.
P Thuss-PatienceCharite University Medicine Berlin, Medical Clinic of Hematology, Oncology and Tumor Immunology, Berlin.
T EttrichDepartment of Internal Medicine I, Ulm University Hospital, Ulm.
D ArnoldAsklepios Tumorzentrum Hamburg, AK Altona, Hamburg.
F BassermannKlinikum rechts der Isar, Technische Universität München, Munich.
S E Al-BatranNordwest Hospital, Institute of Clinical Cancer Research, University Cancer Center, Frankfurt.
K WiechenKlinikum Worms gGmbH, Institute for Pathology, Worms, Germany.
K DhaeneMD Dhaene Pathology Lab BVBA, Destelbergen, Belgium.
D MaurusFormerly of Ganymed GmbH (AG), Mainz, Germany.
M GoldFormerly of Ganymed GmbH (AG), Mainz, Germany.
C HuberCi3 - Cluster of Individualized Immune Intervention, Mainz; TRON - Translational Oncology at the University Medical Center of the Johannes Gutenberg University Mainz, Mainz.
A KrivoshikAstellas Pharma, Inc., Northbrook, USA.
A ArozullahAstellas Pharma, Inc., Northbrook, USA.
J W ParkAstellas Pharma, Inc., Northbrook, USA.
M SchulerWest German Cancer Center, University Duisburg-Essen, Essen; German Cancer Consortium (DKTK), Partner site University Hospital Essen, Essen, Germany.
Astellas Pharma (United States) · USJohannes Gutenberg University Mainz · DEAsklepios Klinik Altona · DECentre for Individualised Infection Medicine · DECharité - Universitätsmedizin Berlin · DEEssen University Hospital · DEGoethe University Frankfurt · DEHeidelberg University · DEKantonsspital St. Gallen · CHLeipzig University · DERiga East University Hospital · LVTUM Klinikum · DEUniversity Hospital Ulm · DEUniversity of Applied Sciences Worms · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundClaudin 18.2 (CLDN18.2) is physiologically confined to gastric mucosa tight junctions; however, upon malignant transformation, perturbations in cell polarity lead to CLDN18.2 epitopes being exposed on the cancer cell surface. The first-in-class monoclonal antibody, zolbetuximab (formerly known as IMAB362), binds to CLDN18.2 and can induce immune-mediated lysis of CLDN18.2-positive cells. PATIENTS AND

methodsPatients with advanced gastric, gastro-oesophageal junction (GEJ) or oesophageal adenocarcinomas with moderate-to-strong CLDN18.2 expression in ≥50% of tumour cells received zolbetuximab intravenously every 2 weeks for five planned infusions. At least three patients were enrolled in two sequential cohorts (cohort 1300 mg/m2; cohort 2600 mg/m2); additional patients were enrolled into a dose-expansion cohort (cohort 3600 mg/m2). The primary end point was the objective response rate [ORR: complete and partial response (PR)]; secondary end points included clinical benefit [ORR+stable disease (SD)], progression-free survival, safety/tolerability, and zolbetuximab pharmacokinetic profile.

resultsFrom September 2010 to September 2012, 54 patients were enrolled (cohort 1, n = 4; cohort 2, n = 6; cohort 3, n = 44). Three patients in cohort 1 and 25 patients in cohorts 2/3 received at least 5 infusions. Antitumour activity data were available for 43 patients, of whom 4 achieved PR (ORR 9%) and 6 (14%) had SD for a clinical benefit rate of 23%. In a subgroup of patients with moderate-to-high CLDN18.2 expression in ≥70% of tumour cells, ORR was 14% (n = 4/29). Treatment-related adverse events occurred in 81.5% (n = 44/54) patients; nausea (61%), vomiting (50%), and fatigue (22%) were the most frequent.

conclusionsZolbetuximab monotherapy was well tolerated and exhibited antitumour activity in patients with CLDN18.2-positive advanced gastric or GEJ adenocarcinomas, with response rates similar to those reported for single-agent targeted agents in gastric/GEJ cancer trials. CLINICALTRIALS.GOV NUMBER: NCT01197885.

Indexed as

AdenocarcinomaAgedAntibodies, MonoclonalDrug-Related Side Effects and Adverse ReactionsEsophageal NeoplasmsEsophagogastric JunctionFemaleHumansMaleMiddle AgedNeoplasm Recurrence, LocalStomach NeoplasmsTreatment OutcomeAntibodies, MonoclonalzolbetuximabCLDN18.2gastric cancergastro-oesophageal junction adenocarcinomaIMAB362zolbetuximab

Identifiers

PMID31240302
PMCPMC6771222
OpenAlexW2955746156

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.