zolbetuximab Clinical Trials (2026): 16 Studies for Metastatic Gastroesophageal Junction (GEJ) Adenocarcinoma & Gastric Cancer

Hipa.ai Research · Source: ClinicalTrials.gov / AACT

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16 zolbetuximab clinical trials are catalogued on Hipa.ai from the AACT mirror of ClinicalTrials.gov, spanning 10 indications (including Metastatic Gastroesophageal Junction (GEJ) Adenocarcinoma & Gastric Cancer) and 5,290 total planned enrollment. 4 Phase 3 zolbetuximab trials and 6 Phase 2 are listed. 7 zolbetuximab clinical trials are actively recruiting at 40 U.S. sites across 24 states. Most recent activity: NCT07431281 (Oct 2031).

Where to Participate: All zolbetuximab Trial Sites in the U.S. (40 sites across 24 states)

Every actively recruiting zolbetuximabtrial site, sorted by state then city. Each row links to the trial detail page (eligibility, contacts, full study record). Sites no longer enrolling at the location level are excluded. ClinicalTrials.gov / AACT does not provide street-level addresses; the map link uses the facility's geocoded coordinates where available.

StateFacilityCityTrialMap
ALUAB Medicine - UAB HospitalBirmingham35294NCT06901531Map
CACBCC Global Research - Comprehensive Blood & Cancer CenterBakersfield93309NCT06901531Map
CATOI Clinical ResearchCerritos90703NCT06901531Map
CAUniversity of California, San Diego Moores Cancer CenterLa Jolla92037-0845NCT06901531Map
CAThe Angeles Clinic and Research Institute, West Los Angeles OfficeLos Angeles90025NCT06901531Map
CTHartford HealthCare - Hartford HospitalHartford06102NCT06901531Map
CTYale University School of MedicineNew Haven06510NCT06901531Map
DCMedStar Georgetown University Hospital / Lombardi Comprehensive Cancer CenterWashington D.C.20007NCT06901531Map
GAPiedmont Physician Medical Oncology AtlantaAtlanta30318NCT06901531Map
ILNorthwestern Memorial HospitalChicago60611NCT06901531Map
INFranciscan Health Oncology and Hematology SpecialistsIndianapolis46237NCT06901531Map
IAHolden Comprehensive Cancer CenterIowa City52242NCT06901531Map
KSUniversity of Kansas Cancer CenterWestwood66205NCT06901531Map
KYSaint Elizabeth Medical Center EdgewoodEdgewood41017NCT06901531Map
MDUniversity of Maryland Medical System - University of Maryland Medical CenterBaltimore21021NCT06901531Map
MADana Farber/Harvard Cancer CenterBoston02215NCT06901531Map
MAUniversity of Massachusetts - UMass Chan Medical SchoolWorcester01655NCT06901531Map
MIUniversity of Michigan Health SystemAnn Arbor48109NCT06901531Map
MIBarbara Ann Karmanos Cancer CenterDetroit48201NCT06901531Map
MIHenry Ford Cancer Institute-Henry Ford HospitalDetroit48201NCT06901531Map
MIResearch SiteGrand Rapids49503NCT07431281Map
MNMetro Minnesota Community Oncology Research Consortium (MMCORC)Saint Louis Park55426NCT06901531Map
MOResearch SiteSt Louis63110NCT07431281Map
NEOncology Hematology West PC dba Nebraska Cancer SpecialistsOmaha68130NCT06901531Map
NEUniversity of Nebraska Medical CenterOmaha68105NCT06901531Map
NJResearch SiteEast Brunswick08816NCT07431281Map
NJCapital Health - Hematology Oncology SpecialistsPennington08534NCT06901531Map
NYNYU Langone Medical CenterNew York10016NCT06901531Map
NYMontefiore Medical CenterThe Bronx10461NCT06901531Map
NCUniversity of North Carolina at Chapel HillChapel Hill27599NCT06901531Map
NCDuke University Medical Center - Duke Cancer CentreDurham27710NCT06901531Map
PAAllegheny General Hospital (AGH)-Allegheny Singer Research InstitutePittsburgh15212NCT06901531Map
RIRhode Island HospitalProvidence02903NCT06901531Map
TNThe University of Tennessee Medical CenterKnoxville37920NCT06901531Map
TNResearch SiteNashville37203NCT07431281Map
TNVanderbilt University Medical CenterNashville37232NCT06901531Map
TXTexas Oncology-Baylor Charles A Sammons Cancer CenterDallas75246NCT06901531Map
TXThe Center For Cancer And Blood Disorders (Texas Cancer Care)Fort Worth76104NCT06901531Map
TXHouston Methodist Cancer CenterHouston77030NCT06901531Map
UTUtah Cancer Specialists Cancer Center - Medical OncologySalt Lake City84106NCT06901531Map

zolbetuximab clinical trials at a glance: phase × recruitment status

Phaserecruitingactive not recruitingcompletednot yet recruitingavailableTotal
P1112
P1/P211
P222116
P3224
N/A1113

Recruiting zolbetuximab clinical trials (7)

Studies currently enrolling participants. Click any NCT ID to view the trial detail page (eligibility, sites, contacts).

NCT IDTitlePhaseIndicationEnrollmentStarted
NCT07431281Sonesitatug Vedotin in Combination With Capecitabine With or Without Rilvegostomig in Participants With Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma Expressing Claudin18.2P3Gastric Cancer2,130Feb 2026
NCT06962137RAINSPOTPhase II RAINSPOT: Zolbetuximab-Paclitaxel-Ramucirumab for CLDN18.2 Positive Gastro-esophageal CancerP2Gastric Cancer Adenocarcinoma Metastatic100Dec 2025
NCT06902545A Study to Observe the Safety of VYLOY (Zolbetuximab) in People in South Korea With Gastric or Gastroesophageal Junction Cancer.Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or Cancer377Apr 2025
NCT06881017Establishment of Precision Targeted Therapy Strategies for Advanced Gastric Cancer Based on Novel Molecular SubtypingP2Gastric Cancer140May 2025
NCT06468280ROSETTESynergistic Effects of PD-1 Antibody and Chemotherapy/Targeted Therapy Followed by Surgery-centric Local Treatment in Patients With Limited-metastatic Gastric CancerP2Gastric Cancer84Nov 2024
NCT06901531LUCERNAA Study of Zolbetuximab Together With Pembrolizumab and Chemotherapy in Adults With Gastric CancerP3Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or Cancer500May 2025
NCT06732856NEO-CLAUDA Phase Ib/II Trial of Neoadjuvant Zolbetuximab Plus Docetaxel, Oxaliplatin and S-1 Chemotherapy in Patients With Locally Advanced Gastric CancerP1/P2Stomach Neoplasm57Apr 2025

zolbetuximab clinical trials by indication

Gastric Cancer (4)

NCTAcronymPhaseStatusTitle
NCT07431281P3recruitingSonesitatug Vedotin in Combination With Capecitabine With or Without Rilvegostomig in Participants With Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma Expressing Claudin18.2
NCT06881017P2not yet recruitingEstablishment of Precision Targeted Therapy Strategies for Advanced Gastric Cancer Based on Novel Molecular Subtyping
NCT06468280ROSETTEP2recruitingSynergistic Effects of PD-1 Antibody and Chemotherapy/Targeted Therapy Followed by Surgery-centric Local Treatment in Patients With Limited-metastatic Gastric Cancer
NCT03528629GEJN/AcompletedA Study of IMAB362 in Japanese Subjects With Locally Advanced or Metastatic Gastric or Gastro-esophageal Junction (GEJ) Adenocarcinoma

Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or Cancer (4)

NCTAcronymPhaseStatusTitle
NCT06902545N/ArecruitingA Study to Observe the Safety of VYLOY (Zolbetuximab) in People in South Korea With Gastric or Gastroesophageal Junction Cancer.
NCT06901531LUCERNAP3recruitingA Study of Zolbetuximab Together With Pembrolizumab and Chemotherapy in Adults With Gastric Cancer
NCT03653507GLOWP3active not recruitingA 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).
NCT03504397SpotlightP3active not recruitingA Study to Compare Zolbetuximab (IMAB362) and Chemotherapy With Placebo and Chemotherapy in Adults With Gastric Cancer.

Gastric Cancer Adenocarcinoma Metastatic (1)

NCTAcronymPhaseStatusTitle
NCT06962137RAINSPOTP2recruitingPhase II RAINSPOT: Zolbetuximab-Paclitaxel-Ramucirumab for CLDN18.2 Positive Gastro-esophageal Cancer

Metastatic Pancreatic Adenocarcinoma (1)

NCTAcronymPhaseStatusTitle
NCT06396091P1active not recruitingA Study of Zolbetuximab With Chemotherapy in Adults With Pancreatic Cancer

Stomach Neoplasm (1)

NCTAcronymPhaseStatusTitle
NCT06732856NEO-CLAUDP1/P2recruitingA Phase Ib/II Trial of Neoadjuvant Zolbetuximab Plus Docetaxel, Oxaliplatin and S-1 Chemotherapy in Patients With Locally Advanced Gastric Cancer

Gastric or Gastro-esophageal Junction (GEJ) Adenocarcinoma (1)

NCTAcronymPhaseStatusTitle
NCT04086758IMAB362P1completedA Pharmacokinetic Study of Zolbetuximab (IMAB362) in Chinese Subjects With Locally Advanced Unresectable or Metastatic Gastric or Gastro-esophageal Junction (GEJ) Adenocarcinoma

Pancreatic Cancer (1)

NCTAcronymPhaseStatusTitle
NCT03816163IMAB362P2active not recruitingA Study of Zolbetuximab (IMAB362) in Adults With Pancreatic Cancer

Pharmacokinetics of Zolbetuximab (1)

NCTAcronymPhaseStatusTitle
NCT03505320ILUSTROP2active not recruitingA Study of Zolbetuximab (IMAB362) in Adults With Gastric Cancer

CLDN18.2-positive Adenocarcinoma of the Gastroesophageal Junction (1)

NCTAcronymPhaseStatusTitle
NCT01630083FASTP2completedEfficacy and Safety of IMAB362 in Combination With the EOX Regimen for CLDN18.2-positive Gastric Cancer

Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma Cancer (1)

NCTAcronymPhaseStatusTitle
NCT06048081N/AavailableEarly Access Program for Zolbetuximab

zolbetuximab pivotal trial highlights (Phase 2/3/4)

Phase-2/3/4 studies with named acronyms — the registration-grade trials most cited in label discussions and Wikipedia.

AcronymNCTPhaseStatusIndicationEnrollmentPubMed
LUCERNANCT06901531P3recruitingLocally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or Cancer500
GLOWNCT03653507P3active not recruitingLocally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or Cancer507
SpotlightNCT03504397P3active not recruitingLocally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or Cancer565
RAINSPOTNCT06962137P2recruitingGastric Cancer Adenocarcinoma Metastatic100
ROSETTENCT06468280P2recruitingGastric Cancer84
ILUSTRONCT03505320P2active not recruitingPharmacokinetics of Zolbetuximab143
IMAB362NCT03816163P2active not recruitingPancreatic Cancer393
FASTNCT01630083P2completedCLDN18.2-positive Adenocarcinoma of the Gastroesophageal Junction252

All zolbetuximab trials (16)

Sorted by most recent activity (completion → start → posted date). Each row links to the trial detail page on Hipa.ai.

NCT IDAcronymTitlePhaseStatusEnrollmentSponsorStarted
NCT07431281Sonesitatug Vedotin in Combination With Capecitabine With or Without Rilvegostomig in Participants With Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma Expressing Claudin18.2P3recruiting2,130AstraZenecaFeb 2026
NCT06962137RAINSPOTPhase II RAINSPOT: Zolbetuximab-Paclitaxel-Ramucirumab for CLDN18.2 Positive Gastro-esophageal CancerP2recruiting100Universitaire Ziekenhuizen KU LeuvenDec 2025
NCT06902545A Study to Observe the Safety of VYLOY (Zolbetuximab) in People in South Korea With Gastric or Gastroesophageal Junction Cancer.recruiting377Astellas Pharma Korea, Inc.Apr 2025
NCT06881017Establishment of Precision Targeted Therapy Strategies for Advanced Gastric Cancer Based on Novel Molecular SubtypingP2not yet recruiting140China Medical University, ChinaMay 2025
NCT06468280ROSETTESynergistic Effects of PD-1 Antibody and Chemotherapy/Targeted Therapy Followed by Surgery-centric Local Treatment in Patients With Limited-metastatic Gastric CancerP2recruiting84Shanghai Zhongshan HospitalNov 2024
NCT06901531LUCERNAA Study of Zolbetuximab Together With Pembrolizumab and Chemotherapy in Adults With Gastric CancerP3recruiting500Astellas Pharma Global Development, Inc.May 2025
NCT06732856NEO-CLAUDA Phase Ib/II Trial of Neoadjuvant Zolbetuximab Plus Docetaxel, Oxaliplatin and S-1 Chemotherapy in Patients With Locally Advanced Gastric CancerP1/P2recruiting57Asan Medical CenterApr 2025
NCT03505320ILUSTROA Study of Zolbetuximab (IMAB362) in Adults With Gastric CancerP2active not recruiting143Astellas Pharma Global Development, Inc.Jun 2018
NCT03653507GLOWA 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).P3active not recruiting507Astellas Pharma Global Development, Inc.Nov 2018
NCT03504397SpotlightA Study to Compare Zolbetuximab (IMAB362) and Chemotherapy With Placebo and Chemotherapy in Adults With Gastric Cancer.P3active not recruiting565Astellas Pharma Global Development, Inc.Jun 2018
NCT03816163IMAB362A Study of Zolbetuximab (IMAB362) in Adults With Pancreatic CancerP2active not recruiting393Astellas Pharma Global Development, Inc.Mar 2019
NCT06396091A Study of Zolbetuximab With Chemotherapy in Adults With Pancreatic CancerP1active not recruiting12Astellas Pharma Global Development, Inc.Sep 2025
NCT06048081Early Access Program for Zolbetuximabavailable0Astellas Pharma Global Development, Inc.
NCT04086758IMAB362A Pharmacokinetic Study of Zolbetuximab (IMAB362) in Chinese Subjects With Locally Advanced Unresectable or Metastatic Gastric or Gastro-esophageal Junction (GEJ) AdenocarcinomaP1completed12Astellas Pharma China, Inc.Oct 2019
NCT03528629GEJA Study of IMAB362 in Japanese Subjects With Locally Advanced or Metastatic Gastric or Gastro-esophageal Junction (GEJ) AdenocarcinomaN/Acompleted18Astellas Pharma IncJun 2018
NCT01630083FASTEfficacy and Safety of IMAB362 in Combination With the EOX Regimen for CLDN18.2-positive Gastric CancerP2completed252Astellas Pharma Global Development, Inc.Jul 2012

zolbetuximab clinical trials: frequently asked questions

How many zolbetuximab clinical trials are there?
16 zolbetuximab clinical trials are catalogued on Hipa.ai, sourced from the AACT mirror of ClinicalTrials.gov. 6 are actively recruiting participants. 3 are marked completed.
Are zolbetuximab clinical trials recruiting in 2026?
Yes — 6 zolbetuximab trials are actively recruiting in 2026, with 40 U.S. sites across 24 states. See the recruiting trials and the per-state site list further down this page.
What conditions is zolbetuximab being studied for?
zolbetuximab is being studied for Metastatic Gastroesophageal Junction (GEJ) Adenocarcinoma, Gastric Cancer, Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or Cancer, Locally Advanced Unresectable Gastric Adenocarcinoma or Cancer, Metastatic Gastric Adenocarcinoma or Cancer and 23 more. The trials are grouped by indication on this page.
What phase is zolbetuximab in?
zolbetuximab clinical trials span 4 Phase 3, 6 Phase 2, 2 Phase 1. The phase × status matrix at the top of this page breaks down counts by phase and recruitment status.
Who sponsors zolbetuximab clinical trials?
The lead sponsor across the most zolbetuximab trials is Astellas Pharma Global Development, Inc., with 8 additional lead sponsors listed in the data. Each trial row links to the full study detail page including sponsor information.

Sources and methodology

Trial inventory derived from the AACT mirror of ClinicalTrials.gov. Trials are filtered to those naming zolbetuximabas an intervention. Phase, status, enrollment, sponsor, and dates are taken from the source `studies` table; primary indication is the first listed condition. Acronyms are extracted from each trial's brief title where present. PubMed links are populated for trials whose published primary outcomes have been indexed in our evidence cache.

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