NCT06083662

Neratinib and Trastuzumab Biosimilar in Patients with HER2 Mutated Advanced Solid Cancers

Phase II Basket Trial to Evaluate Safety and Efficacy of Neratinib, an Irreversible Tyrosine Kinases Inhibitor of EGFR, ERBB2 and ERBB4 Receptors and Trastuzumab Biosimilar (Herzuma®) in Patients with HER2 Mutated Advanced Solid Cancers

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Korea University Guro Hospital · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

Prospective, Basket, Open-label, Multi-dose, Single-arm, Simon's two-stage, Multi-center trial Study drug : neratinib + herzuma (trastuzumab biosimilar)

Detailed description

1. Primary objective Evaluate overall response rate (ORR) in HER2 mutated advanced solid cancer patients based on RECIST v1.1 2. Secondary objectives (1) Evaluate clinical benefit rate (CBR) (2) Evaluate duration of response (DOR) (3) Evaluate progression free survival (PFS) (4) Evaluate overall survival (OS) (5) Evaluate compliance with oral administration 3) Safety evaluation 1. Evaluate the overall safety of the test drug 2. Evaluate the predefined adverse event (diarrhea)

Conditions

• Metastatic Cancer
• HER2 Gene Mutation

Interventions

Type	Name	Description
DRUG	Neratinib Maleate	* neratinib 240mg po daily * herzuma 8mg/kg (loading) --\> 6mg/kg q3w

Timeline

• Start date: 2021-06-15
• Primary completion: 2023-11-30
• Completion: 2024-12-30
• First posted: 2023-10-16
• Last updated: 2025-03-18

Locations

1 site across 1 country: South Korea