Evidence map›Paper›PMID 37490286›Full record

Trial reportClinical cancer research : an official journal of the American Association for Cancer Research2023

ILUSTRO: Phase II Multicohort Trial of Zolbetuximab in Patients with Advanced or Metastatic Claudin 18.2-Positive Gastric or Gastroesophageal Junction Adenocarcinoma.

Samuel J Klempner, Keun-Wook Lee, Kohei Shitara, Jean-Phillippe Metges, Sara Lonardi, David H Ilson, Nicola Fazio, Tae Yong Kim, Li-Yuan Bai, Diarmuid Moran and 6 more

Open access · hybridAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Clinical cancer research : an official journal of the American Association for Cancer Research, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 64 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
64citing papers in PubMed, 1 pooled it
15.6field-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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

64 citing papers in PubMed, 1 synthesis or guideline pooled it, 68 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Review
  5. Article
  6. Review
  7. Targeting claudins in cancer.Nature reviews. Drug discovery · 2026
    Review
  8. Claudin 18.2 Targeting: A Pan-Cancer Perspective.Clinical cancer research : an official journal of the American Association for Cancer Research · 2026
    Review
  9. Review
  10. Review
  11. Review
  12. Review
  13. Review
  14. Article
  15. Review
  16. Article
  17. Article
  18. Article
  19. Article
  20. Review

4 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

16 authors at 13 institutions in 7 countries.

Samuel J KlempnerDepartment of Medicine, Division of Hematology-Oncology, Massachusetts General Hospital Cancer Center, Boston, Massachusetts.ORCID 0000-0002-4062-0808
Keun-Wook LeeDivision of Hematology and Medical Oncology, Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, South Korea.ORCID 0000-0002-8491-703X
Kohei ShitaraDepartment of Gastroenterology and Gastrointestinal Oncology, National Cancer Center Hospital East, Kashiwa, Japan.ORCID 0000-0001-5196-3630
Jean-Phillippe MetgesInstitut de Cancérologie et d'Hématologie, ARPEGO Network CHU Morvan, Brest, France.ORCID 0000-0003-0728-0861
Sara LonardiMedical Oncology 1, Veneto Institute of Oncology IOV-IRCCS, Padua, Italy.ORCID 0000-0002-7593-8138
David H IlsonGastrointestinal Oncology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York.ORCID 0000-0003-0831-2247
Nicola FazioDivision of Gastrointestinal Medical Oncology and Neuroendocrine Tumors, European Institute of Oncology, IEO, IRCCS, Milan, Italy.ORCID 0000-0001-6869-0704
Tae Yong KimDepartment of Internal Medicine, Seoul National University Hospital, Seoul, South Korea.ORCID 0000-0002-3930-6766
Li-Yuan BaiDivision of Hematology and Oncology, Department of Internal Medicine, China Medical University Hospital, and College of Medicine, China Medical University, Taichung, Taiwan.ORCID 0000-0001-7739-4077
Diarmuid MoranAstellas Pharma, Inc, Northbrook, Illinois.ORCID 0009-0002-9812-7239
Jianning YangAstellas Pharma, Inc, Northbrook, Illinois.ORCID 0009-0009-9868-7915
Ahsan ArozullahAstellas Pharma, Inc, Northbrook, Illinois.ORCID 0000-0002-7433-6610
Jung Wook ParkAstellas Pharma, Inc, Northbrook, Illinois.ORCID 0009-0000-9312-0439
Jeffrey J Raizer *Clinical Sciences, Oncology, Takeda Pharmaceutical Company Limited, Cambridge, Massachusetts.ORCID 0009-0003-8469-2509
Yung-Jue BangDepartment of Internal Medicine, Seoul National University College of Medicine, Seoul, South Korea.ORCID 0000-0001-6000-4597
Manish A ShahDivision of Hematology and Medical Oncology, Weill Cornell Medical College, New York, New York.ORCID 0000-0002-6913-9655
Astellas Pharma (United States) · USCentre Hospitalier Régional Universitaire de Brest · FRChina Medical University · TWCornell University · USEuropean Institute of Oncology · ITIstituto Oncologico Veneto · ITMassachusetts General Hospital · USMemorial Sloan Kettering Cancer Center · USNational Cancer Center Hospital East · JPNew Generation University College · ETSeoul National University Bundang Hospital · KRSeoul National University Hospital · KRTakeda (Japan) · JP

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI SELWYN M VICKERS · 1985 to 2026
$347.4M
NCI NIH HHS P30 CA008748
6 · The paper itself

Abstract

purposeZolbetuximab, an IgG1 monoclonal antibody, binds to claudin 18.2 (CLDN18.2) and mediates tumor cell death through antibody-dependent cellular cytotoxicity and complement-dependent cytotoxicity. We sought to examine zolbetuximab combinations in CLDN18.2-positive HER2-negative gastric/gastroesophageal junction (G/GEJ) adenocarcinoma. PATIENTS AND

methodsThis phase II study assessed efficacy and safety of zolbetuximab, alone or with modified FOLFOX6 (mFOLFOX6) or pembrolizumab, in CLDN18.2-positive advanced/metastatic G/GEJ adenocarcinoma. Patients received zolbetuximab as monotherapy in third/later-line (Cohort 1A, n = 30), with mFOLFOX6 in first-line (Cohort 2, n = 21), or with pembrolizumab in third/later-line (Cohort 3A, n = 3) treatment. The primary endpoint for Cohort 1A was objective response rate (ORR). Key secondary endpoints were ORR (Cohorts 2 and 3A), overall survival (OS; Cohort 1A), and progression-free survival (PFS) and safety (all cohorts).

resultsORR was 0% in Cohorts 1A and 3A, and 71.4% [95% confidence interval (CI), 47.82-88.72] in Cohort 2. Median PFS was 1.54 months (95% CI, 1.31-2.56) in Cohort 1A, 2.96 months (95% CI, 1.48-4.44) in Cohort 3A, and 17.8 months (95% CI, 8.05-25.69) in Cohort 2. Median OS in Cohort 1A was 5.62 months (95% CI, 2.27-11.53). Gastrointestinal adverse events occurred across cohorts [nausea, 63%-90% (grade ≥ 3, 4.8%-6.7%) and vomiting, 33%-67% (grade ≥ 3, 6.7%-9.5%)].

conclusionsZolbetuximab plus mFOLFOX6 demonstrated promising efficacy in previously untreated patients with CLDN18.2-positive G/GEJ adenocarcinoma. These data support the first-line development of zolbetuximab in patients whose tumors are CLDN18.2-positive. Across cohorts, zolbetuximab treatment was tolerable with no new safety signals.

Indexed as

AdenocarcinomaAntibodies, MonoclonalClaudinsEsophageal NeoplasmsStomach NeoplasmsAntineoplastic Combined Chemotherapy ProtocolsEsophagogastric JunctionHumansAntibodies, MonoclonalClaudinsCLDN18 protein, humanzolbetuximab

Identifiers

PMID37490286
PMCPMC10543966
OpenAlexW4385230862

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

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.