OncoMatch/Clinical Trials/NCT07176312
Zanidatamab in Combination With Pembrolizumab and Chemotherapy in HER2 and PD-L1 Positive Metastatic Gastroesophageal Adenocarcinoma (GEA) Patients
Is NCT07176312 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Zanidatamab and Pembrolizumab for gastroesophageal adenocarcinoma.
Treatment: Zanidatamab · Pembrolizumab · mFOLFOX — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Esophageal Carcinoma
Gastric Cancer
Biomarker criteria
Required: HER2 (ERBB2) overexpression (IHC 3+ or IHC 2+ with ISH+) (IHC 3+ or IHC 2+ with ISH+)
HER2-positive (defined as IHC 3+ or IHC 2+ with ISH+)
Required: PD-L1 (CD274) overexpression (CPS ≥ 1) (CPS ≥ 1)
PD-L1-positive (combined positive score CPS ≥ 1)
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: HER2-targeted therapy
Patient received prior anti HER2-targeted treatment for GEA.
Lab requirements
Blood counts
Absolute number of neutrophils (ANC) ≥ 1.5 x 10^9/L; Platelets ≥ 100x10^3/µL
Kidney function
Serum creatinine ≤ 1.5 x ULN or creatinine clearance (measured by 24 h urine) ≥ 30 mL/min
Liver function
AST (SGOT) and ALT (SGPT) ≤ 3.0 x ULN (or ≤ 5.0 x ULN if liver metastases are present); Total Bilirubin ≤ 1.5 x ULN (or < 3.0 x ULN in case of prior liver involvement or Gilbert's Syndrome)
Cardiac function
LVEF ≥ 50%
Patient has adequate hepatic, renal and hematologic functions: 1. Absolute number of neutrophils (ANC) ≥ 1.5 x 10^9/L 2. Platelets ≥ 100x10^3/µL 3. Serum creatinine ≤ 1.5 x ULN or creatinine clearance (measured by 24 h urine) ≥ 30 mL/min ... AST (SGOT) and ALT (SGPT) ≤ 3.0 x ULN (or ≤ 5.0 x ULN if liver metastases are present) ... Total Bilirubin ≤ 1.5 x ULN (or < 3.0 x ULN in case of prior liver involvement or Gilbert's Syndrome) ... Patient has abnormal baseline left ventricular ejection fraction (LVEF < 50 %) [excluded]
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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