Loading clinical trials...

Neratinib and Trastuzumab Biosimilar in Patients with HER2 Mutated Advanced Solid Cancers | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

NCT06083662•Korea University Guro Hospital

View on ClinicalTrials.gov

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)

Eligibility

Age

19 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients who voluntarily decide to participate and give written consent after hearing the explanation of the clinical trial and investigational drugs.
•Adult men and women over 19 years old.
•Histological or cytological confirmed advanced solid tumor and confirmed to have HER2 known oncogenic mutations in tumor DNA by K-master panel test using tumor tissues or circulating tumor DNA in blood.
•Patients having at least 1 or more than 1 measurable lesion according to RECIST v 1.1.
•Eastern Cooperative Oncology Group (ECOG) performance status 0\~2.
•Patients whose life expectancy is more than 6 months.
•Metastatic/progressive solid cancer patients who have received one or more than one standard treatment or do not have any treatment option.
•Patients who have agreed to provide plasma/blood samples, the most recent metastatic/progressive tumor sample or new tumor biopsy for gene sequencing and other biomarker analysis.

Exclusion Criteria

•Patients who received radiotherapy or surgical treatment within 2 weeks prior to the initiation of investigational product.
•Patients having symptomatic brain metastasis who needs treatment. Patients with stable brain metastasis who need no treatment including steroid are eligible
•Inappropriate HER2 mutation (e.g., non-Hot Spot mutation, variant of unknown siginificance, subclonal mutation, premature STOP codon or the Frame Shift mutation).
•Patients having difficulties in swallowing tablets.
•Patients with toxicities of prior treatment which are not recovered to baseline level or ≤ Grade 1.
•Inadequate organ functions:
•1. Hemoglobin (Hemoglobin) \< 8 .0g / dL
•2. Absolute neutrophil count (ANC) \< 1. 0 x10 ³ per mm³
•3. Platelet count \< 100 x10⁹/L (100 ,000/ mm³)
•4. Total bilirubin \> 1.5 x upper normal limits (UNL), (exclude Gilbert's syndrome)
+3 more criteria

Locations (1)

Korea university Guro hospital

Seoul, South Korea

Key Dates

Start Date

June 15, 2021

Primary Completion Date

November 30, 2023

Completion Date

December 30, 2024

Last Updated

March 18, 2025

Enrollment

ACTUAL participants

Conditions

Metastatic CancerHER2 Gene Mutation

Interventions

Neratinib Maleate

DRUG

A Study of ART0380 for the Treatment of Advanced or Metastatic Solid Tumors

NCT04657068

Advanced CancerMetastatic Cancer+7 more

View study

RECRUITINGPHASE1

Y-NM600 in Patients Receiving Anti-PD-1 or Anti-PD-L1 for Metastatic Cancer

NCT07197671

Metastatic Cancer

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 18, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Study of ART0380 for the Treatment of Advanced or Metastatic Solid Tumors

Y-NM600 in Patients Receiving Anti-PD-1 or Anti-PD-L1 for Metastatic Cancer

The Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)

Palliative Spatially Fractionated (GRID) Radiotherapy Using Intensity Modulated Proton Therapy

Study of TJ033721 (Givastomig) in Subjects With Advanced or Metastatic Solid Tumors

STM-06: POLARIS-POlymetastic Lesion Ablative Radiotherapy With Immunotherapy Study