zolbetuximab

DRUG17 trials

Sponsors

Karolinska University Hospital, Astellas Pharma Global Development, Inc., Astellas Pharma Inc, Astellas Pharma China, Inc., Shanghai Zhongshan Hospital

Conditions

CLDN18.2-positive Adenocarcinoma of EsophagusCLDN18.2-positive Adenocarcinoma of the Gastroesophageal JunctionCLDN18.2-positive Gastric AdenocarcinomaEsophageal CancerGastric (Stomach) CancerGastric Adenocarcinoma and Gastroesophageal Junction AdenocarcinomaGastric CancerGastric Cancer Adenocarcinoma Metastatic

Phase 1

A Pharmacokinetic Study of Zolbetuximab (IMAB362) in Chinese Subjects With Locally Advanced Unresectable or Metastatic Gastric or Gastro-esophageal Junction (GEJ) Adenocarcinoma

CompletedNCT04086758

Astellas Pharma China, Inc.Gastric or Gastro-esophageal Junction (GEJ) Adenocarcinoma

Start: 2019-10-18End: 2021-01-22Updated: 2024-11-20

A Study of Zolbetuximab With Chemotherapy in Adults With Pancreatic Cancer

Active, not recruitingNCT06396091

Astellas Pharma Global Development, Inc.Metastatic Pancreatic Adenocarcinoma

Start: 2025-09-24End: 2026-07-31Target: 12Updated: 2025-11-13

A Phase Ib/II Trial of Neoadjuvant Zolbetuximab Plus Docetaxel, Oxaliplatin and S-1 Chemotherapy in Patients With Locally Advanced Gastric Cancer

RecruitingNCT06732856

Asan Medical CenterGastric (Stomach) Cancer, Stomach Neoplasm

Start: 2025-04-04End: 2027-12-31Target: 57Updated: 2025-07-28

Phase 2

Efficacy and Safety of IMAB362 in Combination With the EOX Regimen for CLDN18.2-positive Gastric Cancer

CompletedNCT01630083

Astellas Pharma Global Development, Inc.CLDN18.2-positive Adenocarcinoma of Esophagus, CLDN18.2-positive Adenocarcinoma of the Gastroesophageal Junction, CLDN18.2-positive Gastric Adenocarcinoma

Start: 2012-07-19End: 2019-01-31Updated: 2025-06-15

A Study of Zolbetuximab (IMAB362) in Adults With Gastric Cancer

Active, not recruitingNCT03505320

Astellas Pharma Global Development, Inc.Gastric Cancer, Gastro-esophageal Junction (GEJ) Cancer, Pharmacokinetics of Fluorouracil Bolus (5-FU) +2

Start: 2018-06-29End: 2027-05-31Updated: 2026-04-03

A Study of Zolbetuximab (IMAB362) in Adults With Pancreatic Cancer

Active, not recruitingNCT03816163

Astellas Pharma Global Development, Inc.Metastatic Pancreatic Adenocarcinoma, Metastatic Pancreatic Cancer, Pancreatic Cancer

Start: 2019-03-15End: 2026-08-31Updated: 2026-03-12

Synergistic Effects of PD-1 Antibody and Chemotherapy/Targeted Therapy Followed by Surgery-centric Local Treatment in Patients With Limited-metastatic Gastric Cancer

RecruitingNCT06468280

Shanghai Zhongshan HospitalGastric Cancer, GastroEsophageal Cancer

Start: 2024-11-08End: 2028-12-01Target: 84Updated: 2026-01-21

Establishment of Precision Targeted Therapy Strategies for Advanced Gastric Cancer Based on Novel Molecular Subtyping

Not yet recruitingNCT06881017

China Medical University, ChinaCLDN18.2-positive Adenocarcinoma of the Gastroesophageal Junction, Gastric Cancer, HER2 + Gastric Cancer +1

Start: 2025-05-01End: 2029-11-01Target: 140Updated: 2025-03-18

Phase II RAINSPOT: Zolbetuximab-Paclitaxel-Ramucirumab for CLDN18.2 Positive Gastro-esophageal Cancer

RecruitingNCT06962137

Universitaire Ziekenhuizen KU LeuvenGastric Adenocarcinoma and Gastroesophageal Junction Adenocarcinoma, Gastric Cancer Adenocarcinoma Metastatic

Start: 2025-12-11End: 2030-08-30Target: 100Updated: 2025-12-22

Phase 3

A Study to Compare Zolbetuximab (IMAB362) and Chemotherapy With Placebo and Chemotherapy in Adults With Gastric Cancer.

Active, not recruitingNCT03504397

Astellas Pharma Global Development, Inc.Locally Advanced Unresectable Gastric Adenocarcinoma or Cancer, Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or Cancer, Metastatic Gastric Adenocarcinoma or Cancer +1

Start: 2018-06-21End: 2026-09-30Updated: 2026-02-13

A Study of Zolbetuximab (IMAB362) Plus CAPOX Compared With Placebo Plus CAPOX as First-line Treatment of Subjects With Claudin (CLDN) 18.2-positive, HER2-negative, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (GLOW).

Active, not recruitingNCT03653507

Astellas Pharma Global Development, Inc.Locally Advanced Unresectable Gastric Adenocarcinoma or Cancer, Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or Cancer, Metastatic Gastric Adenocarcinoma or Cancer +1

Start: 2018-11-28End: 2026-09-30Updated: 2026-02-06

A Study of Zolbetuximab Together With Pembrolizumab and Chemotherapy in Adults With Gastric Cancer

RecruitingNCT06901531

Astellas Pharma Global Development, Inc.Locally Advanced Unresectable Gastric Adenocarcinoma or Cancer, Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or Cancer, Metastatic Gastric Adenocarcinoma or Cancer +1

Start: 2025-05-22End: 2028-09-30Target: 500Updated: 2026-04-03

Randomised Phase III Trial of First Line Intraperitoneal Paclitaxel and Systemic Therapy versus Systemic Therapy Alone in Gastric Cancer Patients with Peritoneal Metastases

RecruitingCTIS2024-514879-17-00

Karolinska University HospitalGastric cancer

Start: 2025-11-05Target: 96Updated: 2026-01-22

Sonesitatug Vedotin in Combination With Capecitabine With or Without Rilvegostomig in Participants With Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma Expressing Claudin18.2

RecruitingNCT07431281

AstraZenecaEsophageal Cancer, Gastric Cancer, Gastroesophageal Junction Adenocarcinoma

Start: 2026-02-03End: 2031-10-27Target: 2130Updated: 2026-02-24

Unknown Phase

A Study of IMAB362 in Japanese Subjects With Locally Advanced or Metastatic Gastric or Gastro-esophageal Junction (GEJ) Adenocarcinoma

CompletedNCT03528629

Astellas Pharma IncGastric Cancer, Gastro-esophageal Junction (GEJ) Cancer

Start: 2018-06-08End: 2020-06-09Updated: 2024-12-02

Early Access Program for Zolbetuximab

Astellas Pharma Global Development, Inc.Locally Advanced Unresectable Gastric Adenocarcinoma Cancer, Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma Cancer, Metastatic Gastric Adenocarcinoma Cancer +1

Updated: 2025-09-10

A Study to Observe the Safety of VYLOY (Zolbetuximab) in People in South Korea With Gastric or Gastroesophageal Junction Cancer.

RecruitingNCT06902545

Astellas Pharma Korea, Inc.Locally Advanced Unresectable Gastric Adenocarcinoma or Cancer, Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or Cancer, Metastatic Gastric Adenocarcinoma or Cancer +1

Start: 2025-04-03End: 2030-07-31Target: 377Updated: 2026-03-11

Related Papers

First-line zolbetuximab plus mFOLFOX6 and nivolumab in unresectable CLDN18.2-positive gastric or gastroesophageal junction adenocarcinoma: a phase 2 trial

Nature Medicine2026-03-16

Phase 2 ILUSTRO trial of 1L zolbetuximab plus mFOLFOX6 and nivolumab in patients with CLDN18.2+ locally advanced (LA) unresectable or metastatic gastric or gastroesophageal junction (mG/GEJ) adenocarcinoma.

Journal of Clinical Oncology2026-01-10

Zolbetuximab + pembrolizumab and chemotherapy as first-line treatment for patients with CLDN18.2-positive, HER2-negative, PD-L1-positive locally advanced unresectable or metastatic G/GEJ adenocarcinoma: Phase 3, double-blind, randomized trial (LUCERNA).

Journal of Clinical Oncology2026-01-10

Assessment of the impact of proton pump inhibitor (PPI) exposure on survival outcomes in patients with gastric or gastroesophageal junction adenocarcinoma treated with zolbetuximab plus chemotherapy.

Journal of Clinical Oncology2026-01-10

Population pharmacokinetic analysis of fluorouracil and oxaliplatin in the absence or presence of zolbetuximab in locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma.

2025-09-19

Analytical and Clinical Performance of the VENTANA CLDN18 (43-14A) RxDx Assay in Gastric and Gastroesophageal Junction Adenocarcinoma Tissue Samples in SPOTLIGHT and GLOW.

2025-07-16

Synergistic effects of PD-1 antibody and chemotherapy followed by surgery-centric local treatment in patients with limited-metastatic gastric or gastroesophageal adenocarcinoma (ROSETTE trial): an open-label, single-center, randomized phase 2 trial

BMC Cancer2025-06-01

First-line treatment with zolbetuximab plus CAPOX for ClDN18.2-positive gastric or gastroesophageal junction adenocarcinoma: a cost-effectiveness analysis.

2024-11-226 citations

CMG901, a Claudin18.2-specific antibody-drug conjugate, for the treatment of solid tumors.

2024-09-0313 citations

Health-related quality of life in patients with CLDN18.2-positive, locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma: results from the SPOTLIGHT and GLOW clinical trials.

2024-08-1414 citations

Global prevalence of claudin 18 isoform 2 in tumors of patients with locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma

Gastric Cancer2024-07-0252 citations

Final overall survival results from phase 3 SPOTLIGHT study evaluating zolbetuximab + mFOLFOX6 as first-line (1L) treatment for patients (pts) with claudin 18 isoform 2 (CLDN18.2)+, HER2−, locally advanced (LA) unresectable or metastatic gastric or gastroesophageal junction (mG/GEJ) adenocarcinoma.

Journal of Clinical Oncology2024-06-0111 citations

Zolbetuximab plus chemotherapy for locally advanced unresectable or metastatic stomach or gastroesophageal junction cancers: a plain language summary

Future Oncology2024-05-243 citations

Management of nausea and vomiting (N/V) following first-line (1L) zolbetuximab + chemotherapy treatment in claudin-18.2 (CLDN18.2)+, HER2−, locally advanced (LA) unresectable or metastatic gastric or gastroesophageal junction (mG/GEJ) adenocarcinoma: Analysis from the phase 3 SPOTLIGHT and GLOW studies.

Journal of Clinical Oncology2024-01-2015 citations

Clinical pharmacology profile of the claudin 18.2 antibody zolbetuximab.

Journal of Clinical Oncology2024-01-203 citations

Network meta-analysis of global trials of 1L therapies in locally advanced (LA) unresectable or metastatic gastric or gastroesophageal junction (mG/GEJ) adenocarcinoma.

Journal of Clinical Oncology2024-01-20

Zolbetuximab plus CAPOX in CLDN18.2-positive gastric or gastroesophageal junction adenocarcinoma: the randomized, phase 3 GLOW trial.

2023-07-31339 citations

Genomic characterization between <scp>HER2</scp>‐positive and negative gastric cancer patients in a prospective trial

Cancer Medicine2023-06-1612 citations

Global prevalence of CLDN18.2 in patients with locally advanced (LA) unresectable or metastatic gastric or gastroesophageal junction (mG/GEJ) adenocarcinoma: Biomarker analysis of two zolbetuximab phase 3 studies (SPOTLIGHT and GLOW).

Journal of Clinical Oncology2023-06-0120 citations

Phase 2 trial of zolbetuximab in combination with mFOLFOX6 and nivolumab in patients with advanced or metastatic claudin 18.2-positive, HER2-negative gastric or gastroesophageal junction adenocarcinomas.

Journal of Clinical Oncology2023-06-0110 citations

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