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Advanced Gastric CancerZolbetuximabNCT06767449

Zolbetuximab Claudin18.2 Positive, HER2 Negative, Advanced Gastric Cancer

An observational study of Advanced Gastric Cancer, run by Yonsei University at 1 site in South Korea.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

Treatment effectiveness in the real world Adverse effects Tissue samples collected (multiplex IHC to assess PD-L1 expression, MMR gene status, and Claudin18.2) Blood samples collected (ctDNA, scRNAseq, or immune cell profiling) Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Advanced Gastric Cancer
How many people
80 participants
Where
1 siteSouth Korea
Study dates
1 Dec 2024to 1 Dec 2026
How long will I take part?
2 Years
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • Adult, Older adult

Study population: * Treatment effectiveness in the real world (progression-free survival, overall survival, response rate, etc.) * Adverse effects will be evaluated according to the NCI CTCAE v5.0 * Tissue samples collected before treatment, during treatment, and at disease progression will be analyzed using multiplex IHC to assess PD-L1 expression, MMR gene status, and Claudin18.2. Additionally, NGS testing will be conducted to evaluate the correlation with the treatment response to zolbetuximab. * Blood samples will be collected before treatment, during treatment, and after treatment completion to analyze ctDNA, scRNAseq, or immune cell profiling.

Who may be able to join

  • Patient is ≥ 19 years of age at the time of consent.
  • The patient must have histologically confirmed locally advanced, unresectable, or metastatic gastric or gastroesophageal junction adenocarcinoma
  • Patient whose tumor expresses CLDN18.2 in ≥ 75% of tumor cells demonstrating moderate to strong membranous CLDN18 staining as determined by local or central IHC testing.
  • The tumor sample must be HER2-negative (IHC 0, 1+, or IHC 2+/ISH-).
  • The patient must have received Zolbetuximab as a first-line treatment.
  • 1 Patient has ECOG performance status 0 or 1.
Show all 13Show fewer
  • Patient must meet all of the following criteria based on the locally analyzed laboratory tests collected.
  • Hb ≥8 g/dL (For patients who require a transfusion, it is appropriate if Hb ≥9 g/dL after transfusion)
  • ANC ≥1.0 x 10^9/L
  • Platelet ≥75 x 10^9/L
  • Total bilirubin ≤1.5 x ULN without liver metastasis, or <3.0 x ULN if liver metastasis is present
  • AST or ALT ≤2.5 x ULN without liver metastasis, or ≤5 x ULN if liver metastasis is present
  • Estimated creatinine clearance ≥30 mL/min

Who cannot join

  • Patient has previously received treatment in a clinical trial of zolbetuximab, or a clinical trial that included zolbetuximab as 1 of the treatment options, even if the patient was not given zolbetuximab
  • History of known or suspected hypersensitivity to Zolbetuximab, other monoclonal antibodies, or components of the used formulations.
  • Patient has received prior systemic chemotherapy for locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma. However, patient may have received either neo-adjuvant or adjuvant chemotherapy, immunotherapy or other systemic anticancer therapies as long as it was completed at least 6 months prior to participation.
  • Patients who have received systemic immunosuppressive therapy, including systemic corticosteroids, within 14 days before enrollment. However, patients using physiological replacement doses of hydrocortisone or its equivalent (maximum hydrocortisone 30 mg/day or prednisone 10 mg/day), those who have received a single dose of systemic corticosteroid, or those who have received systemic corticosteroids as premedication for radiologic contrast agents are allowed.
  • Patient has a complete gastric outlet syndrome or a partial gastric outlet syndrome with persistent/recurrent vomiting
  • Per investigator judgment, patient has significant gastric bleeding and/or untreated gastric ulcers that would exclude the patient from participation per investigator Judgment
  • Patient has any other condition, which, in the opinion of the treating physician, makes the patient unsuitable to receive or tolerate zolbetuximab.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Sun Young Rha contact

82-2-2227-8406

Rha7655@yuhs.ac

minkyu Jung contact

82-2-2227-8406

minkjung@yuhs.ac

South Korea1 site, 1 recruiting

  • Severance Hospital

    Seoul, 03722

    Recruiting

Other trials in South Korea

About this study

Official title: Multi-center Cohort Study to Evaluate the Real-world Efficacy and Safety of Zolbetuximab Plus Chemotherapy in Claudin18.2 Positive, HER2 Negative, Advanced Gastric Cancer

  • Treatment effectiveness in the real world
  • Adverse effects
  • Tissue samples collected (multiplex IHC to assess PD-L1 expression, MMR gene status, and Claudin18.2)
  • Blood samples collected (ctDNA, scRNAseq, or immune cell profiling)
Read the detailed description
  • Treatment effectiveness in the real world (progression-free survival, overall survival, response rate, etc.)
  • Adverse effects will be evaluated according to the NCI CTCAE v5.0
  • Tissue samples collected before treatment, during treatment, and at disease progression will be analyzed using multiplex IHC to assess PD-L1 expression, MMR gene status, and Claudin18.2. Additionally, NGS testing will be conducted to evaluate the correlation with the treatment response to zolbetuximab.
  • Blood samples will be collected before treatment, during treatment, and after treatment completion to analyze ctDNA, scRNAseq, or immune cell profiling.
Keywords
Zolbetuximab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Treatment effectiveness

    Progression-free survival, overall survival, response rate

    Measured: 2 year

  2. Number of participants with treatment-related adverse events as assessed by CTCAE V5.0

    Adverse effects will be evaluated according to the NCI CTCAE v5.0

    Measured: 2 year

  3. molecular marker Analysis

    • Tissue samples collected before treatment, during treatment, and at disease progression will be analyzed using multiplex IHC to assess PD-L1 expression, MMR gene status, and Claudin18.2. Additionally, NGS testing will be conducted to evaluate the correlation with the treatment response to zolbetuximab.
    • Blood samples will be collected before treatment, during treatment, and after treatment completion to analyze ctDNA, scRNAseq, or immune cell profiling.

    Measured: 2 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jan 2025
  2. Study start1 Dec 2024
  3. Primary completion1 Dec 2026 (estimated)
  4. Study completion1 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
80 participants (estimated)
Target duration
2 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT06767449
Sponsor's protocol ID
4-2024-1274
Acronym
Zolbetuximab
Status last verified
Jan 2025
First submitted
24 Dec 2024
Last updated
9 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.

    PubMed 33538338

  • Niimi T, Nagashima K, Ward JM, Minoo P, Zimonjic DB, Popescu NC, Kimura S. claudin-18, a novel downstream target gene for the T/EBP/NKX2.1 homeodomain transcription factor, encodes lung- and stomach-specific isoforms through alternative splicing. Mol Cell Biol. 2001 Nov;21(21):7380-90. doi: 10.1128/MCB.21.21.7380-7390.2001.

    PubMed 11585919

  • Gunzel D, Yu AS. Claudins and the modulation of tight junction permeability. Physiol Rev. 2013 Apr;93(2):525-69. doi: 10.1152/physrev.00019.2012.

    PubMed 23589827

  • Sahin U, Koslowski M, Dhaene K, Usener D, Brandenburg G, Seitz G, Huber C, Tureci O. Claudin-18 splice variant 2 is a pan-cancer target suitable for therapeutic antibody development. Clin Cancer Res. 2008 Dec 1;14(23):7624-34. doi: 10.1158/1078-0432.CCR-08-1547.

    PubMed 19047087

  • Lee JH, Kim KS, Kim TJ, Hong SP, Song SY, Chung JB, Park SW. Immunohistochemical analysis of claudin expression in pancreatic cystic tumors. Oncol Rep. 2011 Apr;25(4):971-8. doi: 10.3892/or.2011.1132. Epub 2011 Jan 3.

    PubMed 21206985

  • Woll S, Schlitter AM, Dhaene K, Roller M, Esposito I, Sahin U, Tureci O. Claudin 18.2 is a target for IMAB362 antibody in pancreatic neoplasms. Int J Cancer. 2014 Feb 1;134(3):731-9. doi: 10.1002/ijc.28400. Epub 2013 Sep 16.

    PubMed 23900716

  • Sanada Y, Hirose Y, Osada S, Tanaka Y, Takahashi T, Yamaguchi K, Yoshida K. Immunohistochemical study of claudin 18 involvement in intestinal differentiation during the progression of intraductal papillary mucinous neoplasm. Anticancer Res. 2010 Jul;30(7):2995-3003.

    PubMed 20683045

  • Karanjawala ZE, Illei PB, Ashfaq R, Infante JR, Murphy K, Pandey A, Schulick R, Winter J, Sharma R, Maitra A, Goggins M, Hruban RH. New markers of pancreatic cancer identified through differential gene expression analyses: claudin 18 and annexin A8. Am J Surg Pathol. 2008 Feb;32(2):188-96. doi: 10.1097/PAS.0b013e31815701f3.

    PubMed 18223320

  • Shah MA, Shitara K, Ajani JA, Bang YJ, Enzinger P, Ilson D, Lordick F, Van Cutsem E, Gallego Plazas J, Huang J, Shen L, Oh SC, Sunpaweravong P, Soo Hoo HF, Turk HM, Oh M, Park JW, Moran D, Bhattacharya P, Arozullah A, Xu RH. Zolbetuximab plus CAPOX in CLDN18.2-positive gastric or gastroesophageal junction adenocarcinoma: the randomized, phase 3 GLOW trial. Nat Med. 2023 Aug;29(8):2133-2141. doi: 10.1038/s41591-023-02465-7. Epub 2023 Jul 31.

    PubMed 37524953

  • Shitara K, Lordick F, Bang YJ, Enzinger P, Ilson D, Shah MA, Van Cutsem E, Xu RH, Aprile G, Xu J, Chao J, Pazo-Cid R, Kang YK, Yang J, Moran D, Bhattacharya P, Arozullah A, Park JW, Oh M, Ajani JA. Zolbetuximab plus mFOLFOX6 in patients with CLDN18.2-positive, HER2-negative, untreated, locally advanced unresectable or metastatic gastric or gastro-oesophageal junction adenocarcinoma (SPOTLIGHT): a multicentre, randomised, double-blind, phase 3 trial. Lancet. 2023 May 20;401(10389):1655-1668. doi: 10.1016/S0140-6736(23)00620-7. Epub 2023 Apr 15.

    PubMed 37068504

Questions about this trial

What is this clinical trial studying?

An observational study of Advanced Gastric Cancer, run by Yonsei University at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 9 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Sun Young Rha (82-2-2227-8406, Rha7655@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Treatment effectiveness (time frame: 2 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06767449, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2025; AzTrials last refreshed its copy on 8 Nov 2026.

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