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

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

80

Participants

Timeline

Start Date

October 31, 2025

Primary Completion Date

March 31, 2029

Study Completion Date

March 31, 2029

Conditions
Gastroesophageal AdenocarcinomaFirst Line TherapyHER2 + Gastric CancerPDL-1Metastases
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)

All Listed Sponsors
lead

Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

OTHER