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

NCT06083662 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2025-03-18

No results posted yet for this study

Summary

Prospective, Basket, Open-label, Multi-dose, Single-arm, Simon's two-stage, Multi-center trial

Study drug : neratinib + herzuma (trastuzumab biosimilar)

Conditions

Interventions

DRUG

Neratinib Maleate

* neratinib 240mg po daily * herzuma 8mg/kg (loading) --\> 6mg/kg q3w

Sponsors & Collaborators

  • Korean Cancer Study Group

    collaborator OTHER

  • Korea University Guro Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-15
Primary Completion
2023-11-30
Completion
2024-12-30

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06083662 on ClinicalTrials.gov