# 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

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## TL;DR

Paper by Peter Thuss-Patience indexed on Europe PMC as PubMed record 31240302, in Annals of Oncology (2019), one of the most cited records naming an author with this name at Charité Universitätsmedizin Berlin.

## Summary

Background: Claudin 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 methods: Patients 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.

Results: From 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.

Conclusions: Zolbetuximab 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 on Europe PMC as PubMed record 31240302 (DOI 10.1093/annonc/mdz199). Its author list gives "Thuss-Patience P" with the affiliation "Charite University Medicine Berlin, Medical Clinic of Hematology, Oncology and Tumor Immunology, Berlin", which names Charité Universitätsmedizin Berlin; that is how the record was matched to Peter Thuss-Patience, and no figure has been checked by an editor.

## Fields

- Kind: Key paper
- Last checked: 2026-09-22
- Tags: europepmc-ingest
- Journal: Annals of Oncology
- Year: 2019
- DOI: 10.1093/annonc/mdz199
- Authors: Türeci O, Sahin U, Schulze-Bergkamen H, et al.
- What it means: One of the most cited papers Europe PMC returns for Peter Thuss-Patience at Charité Universitätsmedizin Berlin, so it is a natural starting point for reading their work. The record was linked automatically from the author list and affiliation; read the abstract above and the paper itself before relying on any figure.
- Caveats: Matched to the person by surname, initials and an affiliation string naming the institution on the Europe PMC record; the summary reproduces the record's abstract and no figure has been verified against the full paper.; Two authors sharing a surname, initials and institution cannot be told apart by this method; the person's profile links are the place to confirm authorship.

## Sources

- Ann Oncol 2019: https://doi.org/10.1093/annonc/mdz199
- PubMed: https://pubmed.ncbi.nlm.nih.gov/31240302/
- Europe PMC: https://europepmc.org/article/MED/31240302

## Connected records

- people: [Peter Thuss-Patience](https://onco.cc/people/peter-thuss-patience/)
- journals: [Annals of Oncology](https://onco.cc/journals/annals-of-oncology/)

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