OncoMatch/Clinical Trials/NCT05274048
Neratinib and Fam-Trastuzumab Deruxtecan in Advanced Gastro-esophageal Cancer Patients
Is NCT05274048 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including Neratinib Pill and Fam-Trastuzumab Deruxtecan-Nxki (TDxD) for gastric cancer.
Treatment: Neratinib Pill · Fam-Trastuzumab Deruxtecan-Nxki (TDxD) — This is Phase 1 dose finding trial with potential dose expansion to evaluate the safety, toxicity, recommended phase 2 dose (RP2D), and maximum tolerated dose (MTD) of Neratinib plus TDxD using a standard 3+3 dose escalation design in patients with metastatic or unresectable gastro-esophageal cancer that are HER2-overexpressing (IHC 3+ or IHC2+/ISH+) and any other gastrointestinal cancer with HER2 expression with IHC3+. Patients must have progressed or been intolerant of at least one prior line of chemotherapy + HER2 directed therapy.
Check if I qualifyExtracted eligibility criteria
Cancer type
Gastric Cancer
Colorectal Cancer
Hepatocellular Carcinoma
Pancreatic Cancer
Cholangiocarcinoma
Esophageal Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) overexpression (IHC 3+ or IHC2+/ISH+ (gastroesophageal cancer); IHC 3+ (other GI cancers))
HER2-overexpressing: (IHC 3+ or IHC2+/ISH+) advanced gastroesophageal cancer (including gastroesophageal junction adenocarcinoma); IHC 3+ for other GI cancers
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: HER2-targeted therapy — metastatic/unresectable gastroesophageal cancer only
Patients must have received at least one prior line of HER2 directed therapy for metastatic/unresectable disease and completed treatment at least 2 weeks prior to C1D1 (only for Gastroesohageal cancers, not for other GI cancers)
Cannot have received: antibody-drug conjugate (fam-trastuzumab deruxtecan)
must not have received prior treatment with TDxD
Lab requirements
Blood counts
Leukocytes > 3,000/mcL; Absolute neutrophil count > 1,500/mcL; Platelets > 90,000/mcL; Hemoglobin > 9 gm/dl
Kidney function
Creatinine < 2.0mg/dL OR Creatinine clearance > 50 Ml/min/1.73 m2 for patients with creatinine levels above institutional normal
Liver function
Total bilirubin < 2 times institutional normal limits; AST/ALT (SGOT/SGPT) < 5 times institutional normal limits if liver metastases and </+ 2 times institutional normal limits otherwise
Cardiac function
Left Ventricular Ejection Fraction ≥ 45% or lower limit of normal
Patients must have normal organ and marrow function as defined below * Leukocytes > 3,000/mcL * Absolute neutrophil count > 1,500/mcL * Platelets > 90,000/mcL * Hemoglobin > 9 gm/dl * Total bilirubin < 2 times institutional normal limits * AST/ALT (SGOT/SGPT) < 5 times institutional normal limits if liver metastases and </+ 2 times institutional normal limits otherwise * Creatinine < 2.0mg/dL OR * Creatinine clearance > 50 Ml/min/1.73 m2 for patients with creatinine levels above institutional normal Left Ventricular Ejection Fraction ≥ 45% or lower limit of normal.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Stanford Cancer Center · Palo Alto, California
- Roswell Park Comprehensive Cancer Center · Buffalo, New York
- Fox Chase Cancer Center · Philadelphia, Pennsylvania
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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