A Study of Zolbetuximab Together With Pembrolizumab and Chemotherapy in Adults With Gastric Cancer
Public ClinicalTrials.gov record NCT06901531. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 3, Double-blind, Randomized Study of Zolbetuximab in Combination With Pembrolizumab and Chemotherapy (CAPOX or mFOLFOX6) in First-line Treatment of Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma in Participants Whose Tumors Are HER2-negative, Claudin (CLDN) 18.2-positive and Programmed Death-ligand 1 (PD-L1)-Positive
Study identification
- NCT ID
- NCT06901531
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Astellas Pharma Global Development, Inc.
- Industry
- Enrollment
- 500 participants
Conditions and interventions
Conditions
Interventions
- 5-fluorouracil (5-FU) Drug
- Capecitabine Drug
- Folinic acid (leucovorin or local equivalent) Drug
- Oxaliplatin Drug
- Pembrolizumab Drug
- Placebo Drug
- zolbetuximab Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 21, 2025
- Primary completion
- Sep 29, 2028
- Completion
- Sep 29, 2028
- Last update posted
- Apr 28, 2026
2025 – 2028
United States locations
- U.S. sites
- 30
- U.S. states
- 20
- U.S. cities
- 28
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| UAB Medicine - UAB Hospital | Birmingham | Alabama | 35294 | Recruiting |
| TOI Clinical Research | Cerritos | California | 90703 | Recruiting |
| The Angeles Clinic and Research Institute, West Los Angeles Office | Los Angeles | California | 90025 | Recruiting |
| Hartford HealthCare - Hartford Hospital | Hartford | Connecticut | 06102 | Recruiting |
| Yale University School of Medicine | New Haven | Connecticut | 06510 | Recruiting |
| Piedmont Physician Medical Oncology Atlanta | Atlanta | Georgia | 30318 | Recruiting |
| Northwestern Memorial Hospital | Chicago | Illinois | 60611 | Recruiting |
| Franciscan Health Oncology and Hematology Specialists | Indianapolis | Indiana | 46237 | Recruiting |
| Holden Comprehensive Cancer Center | Iowa City | Iowa | 52242 | Recruiting |
| University of Kansas Cancer Center | Westwood | Kansas | 66205 | Recruiting |
| Saint Elizabeth Medical Center Edgewood | Edgewood | Kentucky | 41017 | Recruiting |
| University of Maryland Medical System - University of Maryland Medical Center | Baltimore | Maryland | 21021 | Recruiting |
| Dana Farber/Harvard Cancer Center | Boston | Massachusetts | 02215 | Recruiting |
| University of Michigan Health System | Ann Arbor | Michigan | 48109 | Recruiting |
| Barbara Ann Karmanos Cancer Center | Detroit | Michigan | 48201 | Recruiting |
| Henry Ford Cancer Institute-Henry Ford Hospital | Detroit | Michigan | 48201 | Recruiting |
| Metro Minnesota Community Oncology Research Consortium (MMCORC) | Saint Louis Park | Minnesota | 55426 | Recruiting |
| University of Nebraska Medical Center | Omaha | Nebraska | 68105 | Recruiting |
| Oncology Hematology West PC dba Nebraska Cancer Specialists | Omaha | Nebraska | 68130 | Recruiting |
| NYU Langone Medical Center | New York | New York | 10016 | Recruiting |
| Montefiore Medical Center | The Bronx | New York | 10461 | Recruiting |
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | Recruiting |
| Duke University Medical Center - Duke Cancer Centre | Durham | North Carolina | 27710 | Recruiting |
| Rhode Island Hospital | Providence | Rhode Island | 02903 | Recruiting |
| The University of Tennessee Medical Center | Knoxville | Tennessee | 37920 | Recruiting |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | Recruiting |
| Texas Oncology-Baylor Charles A Sammons Cancer Center | Dallas | Texas | 75246 | Recruiting |
| The Center For Cancer And Blood Disorders (Texas Cancer Care) | Fort Worth | Texas | 76104 | Recruiting |
| Houston Methodist Cancer Center | Houston | Texas | 77030 | Recruiting |
| Utah Cancer Specialists Cancer Center - Medical Oncology | Salt Lake City | Utah | 84106 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 194 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06901531, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 28, 2026 · Synced May 8, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06901531 live on ClinicalTrials.gov.