Actively Recruiting
Zanidatamab in Combination With Pembrolizumab and Chemotherapy in HER2 and PD-L1 Positive Metastatic Gastroesophageal Adenocarcinoma (GEA) Patients
Led by Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest · Updated on 2026-02-04
80
Participants Needed
20
Research Sites
162 weeks
Total Duration
On this page
Sponsors
I
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Lead Sponsor
J
Jazz Pharmaceuticals
Collaborating Sponsor
AI-Summary
What this Trial Is About
The ZANGEA trial is a open-label, single arm, multicenter phase II trial assessing the efficacy of zanidatamab in combination with pembrolizumab and chemotherapy in patients with metastatic gastroesophageal adenocarcinoma (GEA). The patients need to be previously untreated in the palliative setting and tested positive for HER2 and PD-L1.
CONDITIONS
Official Title
Zanidatamab in Combination With Pembrolizumab and Chemotherapy in HER2 and PD-L1 Positive Metastatic Gastroesophageal Adenocarcinoma (GEA) Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient has signed and dated informed consent before any study procedures.
- Patient is willing and able to follow study visits, treatments, and tests.
- Patient is 18 years or older at consent.
- Patient has histologically confirmed unresectable advanced/metastatic HER2-positive and PD-L1-positive gastroesophageal adenocarcinoma.
- Patient has assessable disease per RECIST v1.1.
- Patient has not received previous palliative treatment; prior adjuvant/neoadjuvant therapy allowed if last treatment was at least 6 months ago.
- Patient has ECOG performance status 0 or 1.
- Patient has adequate liver, kidney, and blood function as defined by specific laboratory values.
- Patient has adequate blood clotting function (INR ≤ 1.5, PTT ≤ 5 seconds above ULN unless on anticoagulants).
- Women of childbearing potential have a negative pregnancy test within 7 days before treatment and agree to use contraception during and after treatment for specified periods.
- Male patients sexually active with women of childbearing potential agree to use contraception and refrain from sperm donation during and after treatment.
You will not qualify if you...
- Patient has known allergy or severe hypersensitivity to study drugs or similar antibodies.
- Patient has received prior anti-HER2 treatment for gastroesophageal adenocarcinoma.
- Patient has other malignancies within 5 years except certain low-risk cancers treated with curative intent.
- Patient has untreated central nervous system metastases or unstable neurological status.
- Patient has abnormal heart function (LVEF < 50%).
- Patient has active autoimmune disease requiring systemic treatment, except some controlled conditions.
- Patient requires systemic corticosteroids >10 mg prednisone or immunosuppressants within 14 days before treatment.
- Patient has unresolved significant toxicity from prior therapy above grade 1, except specific mild conditions.
- Patient has serious or uncontrolled medical conditions or infections that may increase trial risks or interfere with treatment.
- Patient tests positive for HIV, hepatitis B, or hepatitis C indicating active infection.
- Patient has history of organ or tissue transplant.
- Patient has been incarcerated or involuntarily institutionalized recently.
- Patient cannot provide informed consent due to lack of understanding.
- Patient has other diseases or conditions that contraindicate trial medications or increase treatment risks.
- Patient is participating in another interventional clinical trial within 30 days before study drug administration.
- Patient has complete absence of DPD enzyme activity or uses medications inhibiting DPD within 4 weeks before enrollment.
- Female patients who are pregnant, breastfeeding, or planning pregnancy within 6 months after treatment end.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 20 locations
1
Charité CVK
Berlin, Germany
Not Yet Recruiting
2
Vivantes Klinikum im Friedrichshain
Berlin, Germany
Not Yet Recruiting
3
Klinikum Bielefeld
Bielefeld, Germany
Not Yet Recruiting
4
Städtisches Klinikum Dresden
Dresden, Germany
Not Yet Recruiting
5
Evang. Kliniken Essen Mitte
Essen, Germany
Not Yet Recruiting
6
Krankenhaus Nordwest
Frankfurt, Germany
Not Yet Recruiting
7
Universitätsklinikum Göttingen
Göttingen, Germany
Not Yet Recruiting
8
Hämatologisch Onkologische Praxis Eppendorf (HOPE)
Hamburg, Germany, 20249
Actively Recruiting
9
Asklepios Klinik Altona
Hamburg, Germany
Actively Recruiting
10
Universitätsklinikum Hamburg Eppendorf
Hamburg, Germany
Actively Recruiting
11
St. Anna Hospital Herne
Herne, Germany
Actively Recruiting
12
Universitätsklinikum Jena
Jena, Germany
Not Yet Recruiting
13
Universitätsmedizin Mainz
Mainz, Germany
Not Yet Recruiting
14
Johannes Wesling Klinikum Minden
Minden, Germany
Not Yet Recruiting
15
Klinikum rechts der Isar der TU München
München, Germany
Actively Recruiting
16
LMU Klinikum München Großhadern
München, Germany
Not Yet Recruiting
17
MVZ für Hämatologie und Onkologie Ravensburg
Ravensburg, Germany
Not Yet Recruiting
18
Krankenhaus Barmherzige Brüder Regensburg
Regensburg, Germany
Not Yet Recruiting
19
Universitätsklinikum Ulm
Ulm, Germany
Actively Recruiting
20
Klinikum Wolfsburg
Wolfsburg, Germany
Not Yet Recruiting
Research Team
A
Alexander Stein, Prof. Dr.
CONTACT
C
Clara Dreyling, Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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