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NCT03505320 · ClinicalTrials.gov registry record · Phase 2
A Study of Zolbetuximab (IMAB362) in Adults With Gastric Cancer
A Phase 2 study of Gastric Cancer and GastroEsophageal Junction (GEJ) Cancer, sponsored by Astellas Pharma Global Development.
- Active
- Registry status
- Phase 2
- Development phase
- 143
- Enrollment target
- 20
- Study locations
NCT03505320: Active Phase 2 study of Gastric Cancer and GastroEsophageal Junction (GEJ) Cancer, sponsored by Astellas Pharma Global Development.
NCT03505320 is a Phase 2 study of Gastric Cancer and GastroEsophageal Junction (GEJ) Cancer that is active but no longer recruiting, run by Astellas Pharma Global Development. The registered enrollment target is 143 participants, below the 318-participant average among 153 other Gastric Cancer trials with a reported enrollment target (55% lower). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03505320, a Phase 2 study of Gastric Cancer and GastroEsophageal Junction (GEJ) Cancer, is active but no longer recruiting, sponsored by Astellas Pharma Global Development.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 143 participants
- Enrollment target
- 20
- Study locations
Study Summary
Zolbetuximab is being studied as a treatment for people with cancer in and around the stomach or cancer where the food pipe (esophagus) joins the stomach (gastroesophageal junction cancer). Most people with this type of cancer have a protein called Claudin 18.2 in their tumor. Zolbetuximab is thought to work by attaching to Claudin 18.2 in their tumor. This switches on the body's immune system to attack the tumor. There is an unmet medical need to treat people with advanced cancer in and around the stomach or gastroesophageal junction cancer. This study will provide more information on zolbetuximab given by itself and in combination with other treatments in adults with advanced stomach or gastroesophageal junction cancer. The study is currently ongoing globally. People in this study will either be treated with zolbetuximab by itself, with zolbetuximab and chemotherapy, with zolbetuximab and a medicine called pembrolizumab, or zolbetuximab with chemotherapy and a medicine called nivolumab. This study is ongoing, but enrollment in any of the treatment options has been completed. In addition, at this stage of the study, treatment in some of these treatment options has completed. The main aim of this study is to check how well zolbetuximab controls tumors when given by itself. Adults with cancer in and around the stomach or gastroesophageal junction cancer can take part. Their cancer is locally advanced unresectable or metastatic and has the CLDN18.2 marker in a tumor sample. Locally advanced means the cancer has spread to nearby tissue. Unresectable means the cancer cannot be removed by surgery. Metastatic means the cancer has spread to other parts of the body. They may have been previously treated with standard therapies. People cannot take part if they need to take medicines to suppress their immune system, have blockages or bleeding in their gut, have specific uncontrollable cancers such as symptomatic or untreated cancers in the nervous system, have a specific
Primary Outcome
The ORR is defined as the proportion of participants with complete or partial objective response based on Response Evaluation Criteria in Solid Tumors (RECIST) V1.1 (assessed by an independent review committee (IRC)).
Conditions Studied
Interventions
- DRUG Pembrolizumab
- DRUG oxaliplatin
- DRUG fluorouracil
- DRUG leucovorin
- DRUG zolbetuximab
Study Locations (20)
Other
- Site FR33001 - Brest
- Site FR33004 - Paris
- Site IT39005 - Milan
- Site IT39002 - Naples
- Site IT39004 - Padua
- Site IT39003 - Pisa
- Site JP81001 - Chiba
- Site JP81002 - Tokyo
- Site JP81003 - Tokyo
- Site KR82002 - Seongnam-si
- Site KR82001 - Seoul
- Site TW88601 - Taichung
California
- The Angeles Clinic and Research Institute - Los Angeles
- UCLA Medical Center - Santa Monica
New York
- Memorial Sloan Kettering Cancer Center - New York
- Weill Cornell Medical College - New York
Nouvelle-Aquitaine
- Site FR33003 - Pessac
- Site FR33002 - Poitiers
Illinois
- University of Chicago - Chicago
Massachusetts
- Mass General / North Shore Can - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 143 participants |
| Start Date | 2018-06-29 |
| Est. Completion | 2027-05-31 |
| Phase | Phase 2 |
What the registry record for NCT03505320 still lists
NCT03505320 is an interventional study that assigns participants to a tested intervention. The registered 143 participants enrollment target is mid-sized for trials with a published cap, below the 318-participant average among 153 other Gastric Cancer trials with a reported enrollment target (55% lower).
The record links to 5 conditions, with Gastric Cancer appearing as the primary indexed condition, and to 5 interventions - of which Pembrolizumab is the first listed.
NCT03505320 names 20 study sites across 6 states, led by Other, California, New York.
Frequently Asked Questions
What is clinical trial NCT03505320 about?
NCT03505320 is a clinical study titled "A Study of Zolbetuximab (IMAB362) in Adults With Gastric Cancer". Zolbetuximab is being studied as a treatment for people with cancer in and around the stomach or cancer where the food pipe (esophagus) joins the stomach (gastroesophageal junction cancer). Most people with this type of cancer have a protein called Claudin 18.2 in their tumor. Zolbetuximab is though...
What is the current status of trial NCT03505320?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 143 participants. The study started on 2018-06-29. Estimated completion is 2027-05-31.
What conditions does trial NCT03505320 study?
This clinical trial studies the following conditions: Gastric Cancer, GastroEsophageal Junction (GEJ) Cancer, Pharmacokinetics of Zolbetuximab, Pharmacokinetics of Oxaliplatin, Pharmacokinetics of Fluorouracil Bolus (5-FU).
What interventions are being tested in trial NCT03505320?
The interventions under investigation include: Pembrolizumab (DRUG), oxaliplatin (DRUG), fluorouracil (DRUG), leucovorin (DRUG), zolbetuximab (DRUG).
Who is sponsoring clinical trial NCT03505320?
This trial is sponsored by Astellas Pharma Global Development, which has 168 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03505320 being conducted?
This trial has 20 study locations across California, Illinois, Massachusetts, New York, Nouvelle-Aquitaine. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03505320's enrollment target sits among peer trials
143 64th of 153 higher than 90 of 153 other Gastric Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Gastric Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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