A Study to Compare Zolbetuximab (IMAB362) and Chemotherapy With Placebo and Chemotherapy in Adults With Gastric Cancer.
Public ClinicalTrials.gov record NCT03504397. 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, Global, Multi-Center, Double-Blind, Randomized, Efficacy Study of Zolbetuximab (IMAB362) Plus mFOLFOX6 Compared With Placebo Plus mFOLFOX6 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
Study identification
- NCT ID
- NCT03504397
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Astellas Pharma Global Development, Inc.
- Industry
- Enrollment
- 565 participants
Conditions and interventions
Conditions
Interventions
- fluorouracil Drug
- folinic acid Drug
- oxaliplatin 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
- Jun 20, 2018
- Primary completion
- Sep 8, 2022
- Completion
- Sep 29, 2026
- Last update posted
- May 3, 2026
2018 – 2026
United States locations
- U.S. sites
- 51
- U.S. states
- 23
- U.S. cities
- 45
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Arizona | Phoenix | Arizona | 85004 | — |
| The University of Arizona Medical Center | Tucson | Arizona | 85724 | — |
| CBCC Global Research, Inc. at Comprehensive Blood and Cancer | Bakersfield | California | 93309 | — |
| City of Hope Nat'l Medical Center | Duarte | California | 91010 | — |
| St. Jude Hospital Yorba Linda | Fullerton | California | 92835 | — |
| Pacific Shores Medical Group | Huntington Beach | California | 92648 | — |
| Loma Linda University | Loma Linda | California | 92354 | — |
| The Angeles Clinic and Research Institute | Los Angeles | California | 90025 | — |
| University of California Davis | Sacramento | California | 95817 | — |
| University of California - San Francisco | San Francisco | California | 94143 | — |
| University of Colorado | Aurora | Colorado | 80045 | — |
| Memorial Sloan Kettering Cancer Center | Middletown | Connecticut | 07748-3052 | — |
| Memorial Cancer Institute - West | Hollywood | Florida | 33021 | — |
| University of Miami | Miami | Florida | 33136 | — |
| Orlando Health Inc | Orlando | Florida | 32806 | — |
| Memorial Hospital West | Pembroke Pines | Florida | 33028 | — |
| Cancer Treatment Centers of America, Atlanta | Newnan | Georgia | 30265 | — |
| Northwestern University Medical Center | Chicago | Illinois | 60611 | — |
| University of Chicago | Chicago | Illinois | 60637 | — |
| Norton Cancer Institute | Louisville | Kentucky | 40217 | — |
| University of Maryland Medical Center(UMMC)Transplant Center | Baltimore | Maryland | 21201 | — |
| Maryland Oncology Hematology | Brandywine | Maryland | 20613 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114-2696 | — |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | — |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | — |
| Karmanos Cancer Institute | Detroit | Michigan | 48201 | — |
| Health Partners Institute | Saint Louis Park | Minnesota | 55426 | — |
| Regions Hospital | Saint Paul | Minnesota | 55101 | — |
| Memorial Sloan Kettering Cancer Center | Basking Ridge | New Jersey | 07920 | — |
| Memorial Sloan Kettering Cancer Center | Montvale | New Jersey | 07645 | — |
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | — |
| Memorial Sloan Kettering Cancer Center | Commack | New York | 11725 | — |
| Memorial Sloan Kettering Cancer Center | Harrison | New York | 10604 | — |
| Mount Sinai School of Medicine | New York | New York | 10029-6574 | — |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | — |
| Stony Brook University Medical Center | Stony Brook | New York | 11794-9452 | — |
| Memorial Sloan Kettering Cancer Center | Uniondale | New York | 11553 | — |
| The Ohio State University Medical Center | Columbus | Ohio | 43210 | — |
| Precision Cancer Research -Dayton Physicians Network | Middletown | Ohio | 45042 | — |
| University of Oklahoma Health Science Center | Oklahoma City | Oklahoma | 73104 | — |
| Earle A. Chiles Research Institute | Portland | Oregon | 97213 | — |
| Oregon Health & Science University | Portland | Oregon | 97239 | — |
| Lancaster General Hospital | Lancaster | Pennsylvania | 17604 | — |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | — |
| Cancer Treatment Centers of America, Philadelphia | Philadelphia | Pennsylvania | 19124 | — |
| Rhode Island Hospital-Lifespan Cancer Institute | Providence | Rhode Island | 02903 | — |
| Sanford Cancer Center | Sioux Falls | South Dakota | 57104 | — |
| The University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | — |
| Inova Dwight and Martha Schar Cancer Institute | Fairfax | Virginia | 22031 | — |
| MultiCare Regional Cancer Center - Gig Harbor | Auburn | Washington | 98801 | — |
| Seattle Cancer Care Alliance | Seattle | Washington | 98109 | — |
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 169 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03504397, 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 May 3, 2026 · Synced May 8, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03504397 live on ClinicalTrials.gov.