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

NCT06083662 | Completed Phase 2

• 1 other identifier: AL20-17
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Metastatic Cancer; HER2 Gene Mutation

Outcome Measures

Primary Outcomes (1)

• overall response rate (ORR)

  ORR according to RECIST v1.1

  at 6 months

Secondary Outcomes (4)

• clinical benefit rate, CBR

  at 6 months

• median duration of response, DOR

  at 6 months

• median progression free survival, PFS

  at 6 months

• safety profiles

  at 6 months

Study Arms (1)

A arm

EXPERIMENTAL

Neratinib + herzuma

Drug: Neratinib Maleate

Interventions

Neratinib Maleate DRUG

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

Also known as: Herzuma

A arm

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:
• Hemoglobin (Hemoglobin) \< 8 .0g / dL
• Absolute neutrophil count (ANC) \< 1. 0 x10 ³ per mm³
• Platelet count \< 100 x10⁹/L (100 ,000/ mm³)
• Total bilirubin \> 1.5 x upper normal limits (UNL), (exclude Gilbert's syndrome)
• Alanine aminotransferase (ALT) or aspartate amino transferase (AST) \> 3 x upper normal limits (UNL) (in case of liver and bone metastases \> 5 x ULN)
• Serum creatinine \>1.5 x upper normal limits (UNL) or \< eGFR 30 mL/min/1.73 m² 7) Left ventricle ejection fraction \<50% by multi-gate obtaining method scan (MUGA) or echocardiogram.
• \) Chronic gastrointestinal disorders of which a main symptom is diarrhea (e.g., Crohn's disease, malabsorption, or grade 2 or more than grade 2 diarrhea according to the NCI CTCAE version 5.0 regardless of etiology).

Sponsors & Collaborators

• Korea University Guro Hospital: lead
• Korean Cancer Study Group: collaborator

Study Sites (1)

Korea university Guro hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

neratinib

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: October 9, 2023
• First Posted: October 16, 2023
• Study Start: June 15, 2021
• Primary Completion: November 30, 2023
• Study Completion: December 30, 2024
• Last Updated: March 18, 2025

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)