Spots Global Cancer Trial Database for Neratinib and Trastuzumab Biosimilar in Patients With HER2 Mutated Advanced Solid Cancers
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Trial Identification
Brief Title: Neratinib and Trastuzumab Biosimilar in Patients With HER2 Mutated Advanced Solid Cancers
Official Title: 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
Study ID: NCT06083662
Interventions
Study Description
Brief 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)
Keywords
Eligibility
Minimum Age: 19 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Korea university Guro hospital, Seoul, , Korea, Republic of
Contact Details
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