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Compound · clinical trials

Zolbetuximab clinical trials

Source: ClinicalTrials.gov, U.S. National Library of Medicine — the 8 trials in our USA, China, UK, Ireland and India registers that name Zolbetuximab as an intervention. Synced 25 Sep 2026
8Current trials
3Recruiting now
3Lead sponsors
5Country registers
Maintained by Sreepriya Prasannan
MSc Digital Transformation of Life Sciences (Innopharma Education / Griffith College); MSc & BSc Botany HSE Spark Ignite 2026 โ€” Top 14 finalist
Compiled from ClinicalTrials.gov registry records ยท Last verified ยท Editorial standards
At a glance

Zolbetuximab is named as an intervention in 8 current clinical trials in our USA, China, UK, Ireland and India registers. 3 are recruiting patients now. The most common phase is Phase 3. The sponsor with the most trials is Astellas Pharma Global Development, Inc (6). The most-studied condition is Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or Cancer.

Trials by status

  • Recruiting338%
  • Active, closed563%

Trials by phase

  • Phase 3450%
  • Phase 2338%
  • Phase 1113%
01

Clinical trials of Zolbetuximab

8 trials
StudyPhaseStatusLead sponsorRegisters
A Study of Zolbetuximab Together With Pembrolizumab and Chemotherapy in Adults With Gastric Cancer
NCT06901531 · ClinicalTrials.gov ↗ · Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or Cancer, Locally Advanced Unresectable Gastric Adenocarcinoma or Cancer, Metastatic Gastric Adenocarcinoma or Cancer
Phase 3 Recruiting Astellas Pharma Global Development, Inc. UK, USA, China
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
NCT07431281 · Gastric Cancer, Gastroesophageal Junction Adenocarcinoma, Esophageal Cancer
Phase 3 Recruiting AstraZeneca UK, USA, India, China
Synergistic Effects of PD-1 Antibody and Chemotherapy/Targeted Therapy Followed by Surgery-centric Local Treatment in Patients With Limited-metastatic Gastric Cancer
NCT06468280 · ClinicalTrials.gov ↗ · Gastric Cancer, GastroEsophageal Cancer
Phase 2 Recruiting Shanghai Zhongshan Hospital China
A Study to Compare Zolbetuximab (IMAB362) and Chemotherapy With Placebo and Chemotherapy in Adults With Gastric Cancer.
NCT03504397 · ClinicalTrials.gov ↗ · Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or Cancer, Locally Advanced Unresectable Gastric Adenocarcinoma or Cancer, Metastatic Gastric Adenocarcinoma or Cancer
Phase 3 Active, closed Astellas Pharma Global Development, Inc. UK, USA, China
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).
NCT03653507 · ClinicalTrials.gov ↗ · Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or Cancer, Locally Advanced Unresectable Gastric Adenocarcinoma or Cancer, Metastatic Gastric Adenocarcinoma or Cancer
Phase 3 Active, closed Astellas Pharma Global Development, Inc. Ireland, UK, USA, China
A Study of Zolbetuximab (IMAB362) in Adults With Gastric Cancer
NCT03505320 · ClinicalTrials.gov ↗ · Pharmacokinetics of Zolbetuximab, Gastric Cancer, Gastro-esophageal Junction (GEJ) Cancer
Phase 2 Active, closed Astellas Pharma Global Development, Inc. USA
A Study of Zolbetuximab (IMAB362) in Adults With Pancreatic Cancer
NCT03816163 · ClinicalTrials.gov ↗ · Pancreatic Cancer, Metastatic Pancreatic Cancer, Metastatic Pancreatic Adenocarcinoma
Phase 2 Active, closed Astellas Pharma Global Development, Inc. Ireland, USA, China
A Study of Zolbetuximab With Chemotherapy in Adults With Pancreatic Cancer
NCT06396091 · ClinicalTrials.gov ↗ · Metastatic Pancreatic Adenocarcinoma
Phase 1 Active, closed Astellas Pharma Global Development, Inc. USA

Registers list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.

02

Zolbetuximab across our data

Ireland · EU · US

The same active substance in our other registers, matched by its exact name. Each entry links to the register record it comes from.

Licensed in Ireland (HPRA)

1 single-substance product containing Zolbetuximab on the HPRA medicines list.

  • Vyloy 100 mg powder for concentrate for solution for infusion.Astellas Pharma Europe B.V. · EU/1/24/1856/001-002
All 1 Irish product →

Supply shortages

No entry for Zolbetuximab in the EMA, FDA or German BfArM shortage lists we track.

03

Conditions studied with Zolbetuximab

14 conditions
Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or Cancer3Locally Advanced Unresectable Gastric Adenocarcinoma or Cancer3Metastatic Gastric Adenocarcinoma or Cancer3Metastatic Gastroesophageal Junction (GEJ) Adenocarcinoma3Gastric Cancer3Metastatic Pancreatic Adenocarcinoma2Pancreatic Cancer1Metastatic Pancreatic Cancer1Gastroesophageal Junction Adenocarcinoma1Esophageal Cancer1Pharmacokinetics of Zolbetuximab1Gastro-esophageal Junction (GEJ) Cancer1
All 14 conditions
Condition (as registered)Trials
Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or Cancer3
Locally Advanced Unresectable Gastric Adenocarcinoma or Cancer3
Metastatic Gastric Adenocarcinoma or Cancer3
Metastatic Gastroesophageal Junction (GEJ) Adenocarcinoma3
Gastric Cancer3
Metastatic Pancreatic Adenocarcinoma2
Pancreatic Cancer1
Metastatic Pancreatic Cancer1
Gastroesophageal Junction Adenocarcinoma1
Esophageal Cancer1
Pharmacokinetics of Zolbetuximab1
Gastro-esophageal Junction (GEJ) Cancer1
Pharmacokinetics of Oxaliplatin1
GastroEsophageal Cancer1
04

Sponsors

lead sponsor per trial
Lead sponsorTrials
Astellas Pharma Global Development, Inc.6
AstraZeneca1
Shanghai Zhongshan Hospital1
05

By country register

RegisterTrialsRecruiting
Clinical trials in USA72
Clinical trials in China63
Clinical trials in UK42
Clinical trials in Ireland20
Clinical trials in India11

A trial with sites in more than one country appears in each of those registers.

06

Related compounds

07

Questions about Zolbetuximab trials

How many clinical trials are testing Zolbetuximab?

8 current trials in our USA, China, UK, Ireland and India registers name Zolbetuximab as a drug or biological intervention, as of the registry sync on 25 September 2026. Completed and withdrawn studies are not counted.

Are Zolbetuximab trials recruiting patients?

Yes. 3 of the 8 trials are recruiting: 2 with sites in USA, 3 with sites in China, 2 with sites in UK and 1 with sites in India. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.

Who sponsors Zolbetuximab clinical trials?

Astellas Pharma Global Development, Inc (6), AstraZeneca (1) and Shanghai Zhongshan Hospital (1). The number in brackets is how many trials each organisation leads.

Is Zolbetuximab licensed in Ireland?

Yes. The HPRA medicines list includes 1 single-substance product containing Zolbetuximab, for example Vyloy 100 mg powder for concentrate for solution for infusion. (Astellas Pharma Europe B.V.). A licence does not mean a product is currently marketed or reimbursed; see each product's record.

Is there a Zolbetuximab shortage?

Not in the lists we track: Zolbetuximab has no entry in the EMA, FDA or German BfArM shortage registers as of their latest sync.

Where does this information come from?

Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Zolbetuximab works or whether it is effective, and it is not medical advice.

How this page is built

Everything on this page is copied from public ClinicalTrials.gov registry records โ€” it is not written from memory, and nothing here describes how Zolbetuximab works or whether it is effective. Each trial links to its own record so you can check it yourself.

This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Zolbetuximab (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 25 Sep 2026.

Please verify before you rely on this. This page is general information for life-science and pharmaceutical professionals. It is not medical advice, and it has not been reviewed by a clinician โ€” our editorial team holds life-science qualifications, not clinical ones. It is not exhaustive and may not reflect the most recent label change. Always check the official prescribing information (US Prescribing Information or EU SmPC) and speak to your doctor or pharmacist before acting on anything here. Drugs in the same class are not automatically interchangeable, and approvals, brand names and indications differ between the US, the EU/Ireland (EMA/HPRA) and other regions. Spotted an error? Tell us โ€” we correct promptly and log it.