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Chemotherapy
Zanidatamab + Chemotherapy ± Tislelizumab for Stomach and Esophageal Cancer (HERIZON-GEA-01 Trial)
Phase 3
Recruiting
Research Sponsored by Jazz Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1, assessed within 3 days prior to randomization
Histologically confirmed unresectable locally advanced, recurrent or metastatic HER2-positive gastroesophageal adenocarcinoma (adenocarcinomas of the stomach or esophagus, including the gastroesophageal junction), defined as 3+ HER2 expression by IHC or 2+ HER2 expression by IHC with ISH positivity per central assessment. Subjects with esophageal adenocarcinoma must not be eligible for combined chemoradiotherapy at the time of enrollment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3.5 years
Awards & highlights
HERIZON-GEA-01 Trial Summary
This trial will test whether zanidatamab, when given with chemotherapy, is more effective than trastuzumab given with chemotherapy.
Who is the study for?
This trial is for adults with advanced HER2-positive stomach or esophageal cancers that can't be removed by surgery or have spread. Participants should be in good physical condition, with a performance status of 0-1 and proper organ function including heart health. They must not have untreated brain metastases, significant heart issues, HIV, recent other cancers, prior treatment with certain cancer drugs including HER2-targeted agents (unless it was for breast cancer over 5 years ago), or known SARS-CoV-2 infection.Check my eligibility
What is being tested?
The study tests if zanidatamab combined with chemotherapy works better and is safer than trastuzumab plus chemotherapy in treating these cancers. Some patients will also receive tislelizumab to see if adding this drug improves outcomes. The effectiveness will be measured against the standard care for this type of cancer.See study design
What are the potential side effects?
Possible side effects include reactions related to the immune system such as inflammation in different organs, infusion-related reactions from the drugs being administered into the bloodstream, fatigue from treatment burden on the body's resources, digestive disturbances due to impact on gastrointestinal tract functions and potential blood disorders stemming from bone marrow suppression.
HERIZON-GEA-01 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
My cancer is advanced stomach or esophagus cancer that cannot be removed by surgery and tests positive for HER2.
HERIZON-GEA-01 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3.5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3.5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall survival
Progression-free survival (PFS) by blinded independent central review (BICR)
Secondary outcome measures
Confirmed ORR per Investigator assessment
Confirmed objective response rate (ORR) by BICR
DOR per Investigator assessment
+9 moreHERIZON-GEA-01 Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Arm CExperimental Treatment6 Interventions
Zanidatamab and tislelizumab plus physician's choice of CAPOX or FP
Group II: Arm BExperimental Treatment5 Interventions
Zanidatamab plus physician's choice of CAPOX or FP
Group III: Arm AActive Control5 Interventions
Trastuzumab (Herceptin®) plus physician's choice of capecitabine plus oxaliplatin (CAPOX) or 5-fluorouracil (5-FU) plus cisplatin (FP)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
5-Fluorouracil
2012
Completed Phase 3
~7800
Oxaliplatin
2011
Completed Phase 4
~2560
Cisplatin
2013
Completed Phase 3
~1940
Tislelizumab
2018
Completed Phase 3
~4260
Capecitabine
2013
Completed Phase 3
~3420
Find a Location
Who is running the clinical trial?
BeiGene, Ltd.UNKNOWN
2 Previous Clinical Trials
130 Total Patients Enrolled
Jazz PharmaceuticalsLead Sponsor
248 Previous Clinical Trials
33,571 Total Patients Enrolled
Zymeworks Inc.Lead Sponsor
10 Previous Clinical Trials
1,595 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am fully active or restricted in physically strenuous activity but can do light work.I have had chemotherapy for advanced stomach or esophagus cancer that couldn't be removed by surgery.I have a history of or currently have leptomeningeal disease.I do not have serious heart conditions like uncontrolled high blood pressure or heart failure.I have been treated with drugs targeting immune checkpoints.My cancer is advanced stomach or esophagus cancer that cannot be removed by surgery and tests positive for HER2.I had COVID-19 but have recovered according to my local health guidelines.I have a history of HIV infection.I have not had HER2 treatment for GEA, except if it was for breast cancer over 5 years ago.I have active hepatitis.My organs are working well.I have another cancer that is not cured or was treated in the last 3 years.I have brain metastases but haven't received treatment for them in the last 4 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: Arm C
- Group 2: Arm B
- Group 3: Arm A
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this a trial that is still recruiting participants?
"That is correct. The clinicaltrials.gov website shows that this trial, which was originally advertised on December 2nd 2021, is still looking for participants. In total, they need 714 patients from 2 different trial sites."
Answered by AI
What are the traditional indications for Zanidatamab?
"Zanidatamab is an effective treatment for duke's c colon cancer as well as other forms of cancer like neoplasm metastasis, inflammatory breast cancer (ibc), and advanced testicular cancer."
Answered by AI
Are there other case studies that feature Zanidatamab?
"Zanidatamab is being studied in 528 Phase 3 clinical trials, 1585 of which are currently active. While the majority of research is based in Seattle, Washington, there are over 77 thousand research sites around the world."
Answered by AI
Has Zanidatamab been cleared by the FDA for general use?
"There is some evidence from efficacy data in clinical trials as well as data from multiple rounds of safety testing that suggests Zanidatamab is safe for use. We rate it a 3 on our Power scale."
Answered by AI
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