zolbetuximab Clinical Trials (2026): 16 Studies for Metastatic Gastroesophageal Junction (GEJ) Adenocarcinoma & Gastric Cancer
Hipa.ai Research · Source: ClinicalTrials.gov / AACT
Synced daily from ClinicalTrials.gov via AACT. Last sync: .
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 47 U.S. sites across 26 states. Most recent activity: NCT07431281 (Oct 2031).
Where to Participate: All zolbetuximab Trial Sites in the U.S. (47 sites across 26 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.
| State | Facility | City | Trial | Map |
|---|---|---|---|---|
| AL | UAB Medicine - UAB Hospital | Birmingham35294 | NCT06901531 | Map |
| CA | CBCC Global Research - Comprehensive Blood & Cancer Center | Bakersfield93309 | NCT06901531 | Map |
| CA | TOI Clinical Research | Cerritos90703 | NCT06901531 | Map |
| CA | University of California, San Diego Moores Cancer Center | La Jolla92037-0845 | NCT06901531 | Map |
| CA | The Angeles Clinic and Research Institute, West Los Angeles Office | Los Angeles90025 | NCT06901531 | Map |
| CT | Hartford HealthCare - Hartford Hospital | Hartford06102 | NCT06901531 | Map |
| CT | Yale University School of Medicine | New Haven06510 | NCT06901531 | Map |
| DC | MedStar Georgetown University Hospital / Lombardi Comprehensive Cancer Center | Washington D.C.20007 | NCT06901531 | Map |
| GA | Piedmont Physician Medical Oncology Atlanta | Atlanta30318 | NCT06901531 | Map |
| IL | Northwestern Memorial Hospital | Chicago60611 | NCT06901531 | Map |
| IL | Research Site | Niles60714 | NCT07431281 | Map |
| IN | Franciscan Health Oncology and Hematology Specialists | Indianapolis46237 | NCT06901531 | Map |
| IA | Holden Comprehensive Cancer Center | Iowa City52242 | NCT06901531 | Map |
| KS | University of Kansas Cancer Center | Westwood66205 | NCT06901531 | Map |
| KY | Saint Elizabeth Medical Center Edgewood | Edgewood41017 | NCT06901531 | Map |
| MD | University of Maryland Medical System - University of Maryland Medical Center | Baltimore21021 | NCT06901531 | Map |
| MA | Dana Farber/Harvard Cancer Center | Boston02215 | NCT06901531 | Map |
| MA | University of Massachusetts - UMass Chan Medical School | Worcester01655 | NCT06901531 | Map |
| MI | University of Michigan Health System | Ann Arbor48109 | NCT06901531 | Map |
| MI | Barbara Ann Karmanos Cancer Center | Detroit48201 | NCT06901531 | Map |
| MI | Henry Ford Cancer Institute-Henry Ford Hospital | Detroit48201 | NCT06901531 | Map |
| MI | Research Site | Grand Rapids49503 | NCT07431281 | Map |
| MN | Research Site | Burnsville55337 | NCT07431281 | Map |
| MN | Metro Minnesota Community Oncology Research Consortium (MMCORC) | Saint Louis Park55426 | NCT06901531 | Map |
| MO | Research Site | Kansas City64132 | NCT07431281 | Map |
| MO | Research Site | St Louis63110 | NCT07431281 | Map |
| NE | Oncology Hematology West PC dba Nebraska Cancer Specialists | Omaha68130 | NCT06901531 | Map |
| NE | University of Nebraska Medical Center | Omaha68105 | NCT06901531 | Map |
| NJ | Research Site | East Brunswick08816 | NCT07431281 | Map |
| NJ | Capital Health - Hematology Oncology Specialists | Pennington08534 | NCT06901531 | Map |
| NY | NYU Langone Medical Center | New York10016 | NCT06901531 | Map |
| NY | Montefiore Medical Center | The Bronx10461 | NCT06901531 | Map |
| NC | University of North Carolina at Chapel Hill | Chapel Hill27599 | NCT06901531 | Map |
| NC | Duke University Medical Center - Duke Cancer Centre | Durham27710 | NCT06901531 | Map |
| PA | Allegheny General Hospital (AGH)-Allegheny Singer Research Institute | Pittsburgh15212 | NCT06901531 | Map |
| PA | Research Site | Pittsburgh15232 | NCT07431281 | Map |
| RI | Rhode Island Hospital | Providence02903 | NCT06901531 | Map |
| SD | Research Site | Sioux Falls57105 | NCT07431281 | Map |
| TN | The University of Tennessee Medical Center | Knoxville37920 | NCT06901531 | Map |
| TN | Research Site | Nashville37203 | NCT07431281 | Map |
| TN | Vanderbilt University Medical Center | Nashville37232 | NCT06901531 | Map |
| TX | Research Site | Dallas75246 | NCT07431281 | Map |
| TX | Texas Oncology-Baylor Charles A Sammons Cancer Center | Dallas75246 | NCT06901531 | Map |
| TX | The Center For Cancer And Blood Disorders (Texas Cancer Care) | Fort Worth76104 | NCT06901531 | Map |
| TX | Houston Methodist Cancer Center | Houston77030 | NCT06901531 | Map |
| UT | Utah Cancer Specialists Cancer Center - Medical Oncology | Salt Lake City84106 | NCT06901531 | Map |
| VA | Inova Schar Cancer Institute Clinical Trials | Fairfax22031 | NCT06901531 | Map |
zolbetuximab clinical trials at a glance: phase × recruitment status
| Phase | recruiting | active not recruiting | completed | not yet recruiting | available | Total |
|---|---|---|---|---|---|---|
| P1 | 1 | 1 | 2 | |||
| P1/P2 | 1 | 1 | ||||
| P2 | 2 | 2 | 1 | 1 | 6 | |
| P3 | 2 | 2 | 4 | |||
| N/A | 1 | 1 | 1 | 3 |
Recruiting zolbetuximab clinical trials (7)
Studies currently enrolling participants. Click any NCT ID to view the trial detail page (eligibility, sites, contacts).
| NCT ID | Title | Phase | Indication | Enrollment | Started |
|---|---|---|---|---|---|
| NCT07431281 | 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 | P3 | Gastric Cancer | 2,130 | Feb 2026 |
| NCT06962137 | RAINSPOTPhase II RAINSPOT: Zolbetuximab-Paclitaxel-Ramucirumab for CLDN18.2 Positive Gastro-esophageal Cancer | P2 | Gastric Cancer Adenocarcinoma Metastatic | 100 | Dec 2025 |
| NCT06902545 | A 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 Cancer | 377 | Apr 2025 |
| NCT06881017 | Establishment of Precision Targeted Therapy Strategies for Advanced Gastric Cancer Based on Novel Molecular Subtyping | P2 | Gastric Cancer | 140 | May 2025 |
| NCT06468280 | ROSETTESynergistic Effects of PD-1 Antibody and Chemotherapy/Targeted Therapy Followed by Surgery-centric Local Treatment in Patients With Limited-metastatic Gastric Cancer | P2 | Gastric Cancer | 84 | Nov 2024 |
| NCT06901531 | LUCERNAA Study of Zolbetuximab Together With Pembrolizumab and Chemotherapy in Adults With Gastric Cancer | P3 | Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or Cancer | 500 | May 2025 |
| NCT06732856 | NEO-CLAUDA Phase Ib/II Trial of Neoadjuvant Zolbetuximab Plus Docetaxel, Oxaliplatin and S-1 Chemotherapy in Patients With Locally Advanced Gastric Cancer | P1/P2 | Stomach Neoplasm | 57 | Apr 2025 |
zolbetuximab clinical trials by indication
Gastric Cancer (4)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT07431281 | — | P3 | recruiting | 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 |
| NCT06881017 | — | P2 | not yet recruiting | Establishment of Precision Targeted Therapy Strategies for Advanced Gastric Cancer Based on Novel Molecular Subtyping |
| NCT06468280 | ROSETTE | P2 | recruiting | Synergistic Effects of PD-1 Antibody and Chemotherapy/Targeted Therapy Followed by Surgery-centric Local Treatment in Patients With Limited-metastatic Gastric Cancer |
| NCT03528629 | GEJ | N/A | completed | A 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)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT06902545 | — | N/A | recruiting | A Study to Observe the Safety of VYLOY (Zolbetuximab) in People in South Korea With Gastric or Gastroesophageal Junction Cancer. |
| NCT06901531 | LUCERNA | P3 | recruiting | A Study of Zolbetuximab Together With Pembrolizumab and Chemotherapy in Adults With Gastric Cancer |
| NCT03653507 | GLOW | P3 | active not recruiting | 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). |
| NCT03504397 | Spotlight | P3 | active not recruiting | A Study to Compare Zolbetuximab (IMAB362) and Chemotherapy With Placebo and Chemotherapy in Adults With Gastric Cancer. |
Gastric Cancer Adenocarcinoma Metastatic (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT06962137 | RAINSPOT | P2 | recruiting | Phase II RAINSPOT: Zolbetuximab-Paclitaxel-Ramucirumab for CLDN18.2 Positive Gastro-esophageal Cancer |
Metastatic Pancreatic Adenocarcinoma (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT06396091 | — | P1 | active not recruiting | A Study of Zolbetuximab With Chemotherapy in Adults With Pancreatic Cancer |
Stomach Neoplasm (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT06732856 | NEO-CLAUD | P1/P2 | recruiting | A 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)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT04086758 | IMAB362 | P1 | completed | A Pharmacokinetic Study of Zolbetuximab (IMAB362) in Chinese Subjects With Locally Advanced Unresectable or Metastatic Gastric or Gastro-esophageal Junction (GEJ) Adenocarcinoma |
Pancreatic Cancer (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT03816163 | IMAB362 | P2 | active not recruiting | A Study of Zolbetuximab (IMAB362) in Adults With Pancreatic Cancer |
Pharmacokinetics of Zolbetuximab (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT03505320 | ILUSTRO | P2 | active not recruiting | A Study of Zolbetuximab (IMAB362) in Adults With Gastric Cancer |
CLDN18.2-positive Adenocarcinoma of the Gastroesophageal Junction (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT01630083 | FAST | P2 | completed | Efficacy 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)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT06048081 | — | N/A | available | Early 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.
| Acronym | NCT | Phase | Status | Indication | Enrollment | PubMed |
|---|---|---|---|---|---|---|
| LUCERNA | NCT06901531 | P3 | recruiting | Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or Cancer | 500 | — |
| GLOW | NCT03653507 | P3 | active not recruiting | Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or Cancer | 507 | — |
| Spotlight | NCT03504397 | P3 | active not recruiting | Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or Cancer | 565 | — |
| RAINSPOT | NCT06962137 | P2 | recruiting | Gastric Cancer Adenocarcinoma Metastatic | 100 | — |
| ROSETTE | NCT06468280 | P2 | recruiting | Gastric Cancer | 84 | — |
| ILUSTRO | NCT03505320 | P2 | active not recruiting | Pharmacokinetics of Zolbetuximab | 143 | — |
| IMAB362 | NCT03816163 | P2 | active not recruiting | Pancreatic Cancer | 393 | — |
| FAST | NCT01630083 | P2 | completed | CLDN18.2-positive Adenocarcinoma of the Gastroesophageal Junction | 252 | — |
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 ID | Acronym | Title | Phase | Status | Enrollment | Sponsor | Started |
|---|---|---|---|---|---|---|---|
| NCT07431281 | 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 | P3 | recruiting | 2,130 | AstraZeneca | Feb 2026 | |
| NCT06962137 | RAINSPOT | Phase II RAINSPOT: Zolbetuximab-Paclitaxel-Ramucirumab for CLDN18.2 Positive Gastro-esophageal Cancer | P2 | recruiting | 100 | Universitaire Ziekenhuizen KU Leuven | Dec 2025 |
| NCT06902545 | A Study to Observe the Safety of VYLOY (Zolbetuximab) in People in South Korea With Gastric or Gastroesophageal Junction Cancer. | — | recruiting | 377 | Astellas Pharma Korea, Inc. | Apr 2025 | |
| NCT06881017 | Establishment of Precision Targeted Therapy Strategies for Advanced Gastric Cancer Based on Novel Molecular Subtyping | P2 | not yet recruiting | 140 | China Medical University, China | May 2025 | |
| NCT06468280 | ROSETTE | Synergistic Effects of PD-1 Antibody and Chemotherapy/Targeted Therapy Followed by Surgery-centric Local Treatment in Patients With Limited-metastatic Gastric Cancer | P2 | recruiting | 84 | Shanghai Zhongshan Hospital | Nov 2024 |
| NCT06901531 | LUCERNA | A Study of Zolbetuximab Together With Pembrolizumab and Chemotherapy in Adults With Gastric Cancer | P3 | recruiting | 500 | Astellas Pharma Global Development, Inc. | May 2025 |
| NCT06732856 | NEO-CLAUD | A Phase Ib/II Trial of Neoadjuvant Zolbetuximab Plus Docetaxel, Oxaliplatin and S-1 Chemotherapy in Patients With Locally Advanced Gastric Cancer | P1/P2 | recruiting | 57 | Asan Medical Center | Apr 2025 |
| NCT03505320 | ILUSTRO | A Study of Zolbetuximab (IMAB362) in Adults With Gastric Cancer | P2 | active not recruiting | 143 | Astellas Pharma Global Development, Inc. | Jun 2018 |
| NCT03653507 | GLOW | 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). | P3 | active not recruiting | 507 | Astellas Pharma Global Development, Inc. | Nov 2018 |
| NCT03504397 | Spotlight | A Study to Compare Zolbetuximab (IMAB362) and Chemotherapy With Placebo and Chemotherapy in Adults With Gastric Cancer. | P3 | active not recruiting | 565 | Astellas Pharma Global Development, Inc. | Jun 2018 |
| NCT03816163 | IMAB362 | A Study of Zolbetuximab (IMAB362) in Adults With Pancreatic Cancer | P2 | active not recruiting | 393 | Astellas Pharma Global Development, Inc. | Mar 2019 |
| NCT06396091 | A Study of Zolbetuximab With Chemotherapy in Adults With Pancreatic Cancer | P1 | active not recruiting | 12 | Astellas Pharma Global Development, Inc. | Sep 2025 | |
| NCT06048081 | Early Access Program for Zolbetuximab | — | available | 0 | Astellas Pharma Global Development, Inc. | — | |
| NCT04086758 | IMAB362 | A Pharmacokinetic Study of Zolbetuximab (IMAB362) in Chinese Subjects With Locally Advanced Unresectable or Metastatic Gastric or Gastro-esophageal Junction (GEJ) Adenocarcinoma | P1 | completed | 12 | Astellas Pharma China, Inc. | Oct 2019 |
| NCT03528629 | GEJ | A Study of IMAB362 in Japanese Subjects With Locally Advanced or Metastatic Gastric or Gastro-esophageal Junction (GEJ) Adenocarcinoma | N/A | completed | 18 | Astellas Pharma Inc | Jun 2018 |
| NCT01630083 | FAST | Efficacy and Safety of IMAB362 in Combination With the EOX Regimen for CLDN18.2-positive Gastric Cancer | P2 | completed | 252 | Astellas 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 47 U.S. sites across 26 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.
Last refreshed .
Related pages on Hipa.ai: