Informations générales (source: ClinicalTrials.gov)
A Randomized, Multicenter, Phase 3 Study of Zanidatamab in Combination With Chemotherapy With or Without Tislelizumab in Subjects With HER2-positive Unresectable Locally Advanced or Metastatic Gastroesophageal Adenocarcinoma (GEA) (HERIZON-GEA-01)
Interventional
Phase 3
Jazz Pharmaceuticals (Voir sur ClinicalTrials)
décembre 2021
mai 2026
28 juin 2025
This study is being done to find out if zanidatamab, when given with chemotherapy plus or
minus tislelizumab, is safe and works better than trastuzumab given with chemotherapy.
The patients in this study will have advanced human epidermal growth factor 2
(HER2)-positive stomach and esophageal cancers that are no longer treatable with surgery
(unresectable) or chemoradiation, and/or have grown or spread to other parts of the body
(metastatic).
Etablissements
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| Centre Hospitalier Universitaire Grenoble Alpes - Hopital Albert Michallon - 38043 - Grenoble - France | Contact (sur clinicalTrials) | ||||
| Centre Léon Berard - 69008 - Lyon - France | Contact (sur clinicalTrials) | ||||
| CHRU de Brest - Hopital Morvan - 42270 - Saint-Priest-en-Jarez - France | Contact (sur clinicalTrials) | ||||
| CHRU de Poitiers La Miletrie - 86021 - Poitiers - France | Contact (sur clinicalTrials) | ||||
| CHU de Bordeaux - Hopital Haut Leveque - 33600 - Pessac - Gironde - France | Contact (sur clinicalTrials) | ||||
| EDOG - Centre Eugene Marquis Centre Regional de Lutte Contre Le Cancer - PPDS - 35000 - Rennes - France | Contact (sur clinicalTrials) | ||||
| EDOG - Institut Bergonie - PPDS - 33000 - Bordeaux - France | Contact (sur clinicalTrials) | ||||
| EDOG Institut de Cancerologie de l'Ouest - PPDS - 44805 - Nantes - France | Contact (sur clinicalTrials) | ||||
| Hôpital de Rangueil - 69437 - Toulouse - France | Contact (sur clinicalTrials) | ||||
| Hôpital Saint Antoine - 94800 - Villejuif - France | Contact (sur clinicalTrials) | ||||
| Sainte-Catherine, Institut du Cancer Avignon Provence - 84000 - Avignon - France | Contact (sur clinicalTrials) | ||||
| Universite de Bourgogne - Faculte de Medecine - IN - 21079 - Dijon - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
- 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
- Assessable (measurable or non-measurable) disease as defined by RECIST 1.1
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1,
assessed within 3 days prior to randomization
- Adequate organ function
- Left ventricular ejection fraction (LVEF) ≥ 50% as determined by either
echocardiogram or multiple gated acquisition scan (MUGA)
- 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
- Assessable (measurable or non-measurable) disease as defined by RECIST 1.1
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1,
assessed within 3 days prior to randomization
- Adequate organ function
- Left ventricular ejection fraction (LVEF) ≥ 50% as determined by either
echocardiogram or multiple gated acquisition scan (MUGA)
- Prior treatment with a HER2-targeted agent, with the exception of subjects who
received HER2-targeted treatment for breast cancer > 5 years prior to initial
diagnosis of GEA
- Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2 or any other antibody or
drug specifically targeting T-cell co-stimulation or checkpoint pathways
- Prior treatment with systemic antineoplastic therapy or intraperitoneal chemotherapy
for unresectable locally advanced, recurrent or metastatic GEA
- Untreated central nervous system (CNS) metastases, symptomatic CNS metastases, or
radiation treatment for CNS metastases within 4 weeks prior to randomization.
Stable, treated brain metastases are allowed (defined as subjects who are completely
off steroids and anticonvulsants and are neurologically stable with no evidence of
radiographic progression for at least 4 weeks prior to randomization)
- Known history of or ongoing leptomeningeal disease (LMD)
- Known additional malignancy that is not considered cured or that has required
treatment within the past 3 years
- Known active hepatitis
- Any history of human immunodeficiency virus (HIV) infection
- Known SARS-CoV-2 infection; subjects with prior infection that has resolved per
local institutions' requirements and screening guidance are eligible
- QTc Fridericia (QTcF) > 470 ms
- Clinically significant cardiac disease, such as ventricular arrhythmia requiring
therapy, uncontrolled hypertension or any history of symptomatic congestive heart
failure (CHF)