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Zanidatamab in Combination With Pembrolizumab and Chemotherapy in HER2 and PD-L1 Positive Metastatic Gastroesophageal Adenocarcinoma (GEA) Patients

NCT07176312 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-02-04

No results posted yet for this study

Summary

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

  • Gastroesophageal Adenocarcinoma
  • First Line Therapy
  • HER2 + Gastric Cancer
  • PDL-1
  • Metastases

Interventions

DRUG

Zanidatamab

Zanidatamab 1,200 mg (patients \<70 kg at baseline) or 1,600 mg (patients ≥70 kg at baseline), administered i.v. on day 1 of each 2-week cycle (Q2W)

DRUG

Pembrolizumab

Pembrolizumab 400 mg, administered i.v. on day 1 of every third cycle (Q6W)

DRUG

mFOLFOX

modified FOLFOX with Oxaliplatin 85 mg/m2 i.v. on day 1; Folinic Acid 400 mg/m2 i.v. on day 1; 5-FU 2,400 mg/m2 i.v. continuous infusion over 48 hours (no bolus!) on days 1 and 2 of each 2-week cycle (Q2W)

Sponsors & Collaborators

  • Jazz Pharmaceuticals

    collaborator INDUSTRY

  • Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

    lead OTHER

Principal Investigators

  • Salah-Eddin Al-Batran, Prof. Dr. · Frankfurter Institut für Klinische Krebsforschung IKF GmbH

  • Alexander Stein, Prof. Dr. · Hämatologisch-Onkologische Praxis Eppendorf University Cancer Center Hamburg

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-16
Primary Completion
2029-03-31
Completion
2029-03-31

Countries

  • Germany

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07176312 on ClinicalTrials.gov