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

Trial Title: Neratinib and Trastuzumab Biosimilar in Patients With HER2 Mutated Advanced Solid Cancers

NCT ID: NCT06083662

Condition: Metastatic Cancer
HER2 Gene Mutation

Conditions: Official terms:
Neoplasm Metastasis
Neratinib

Study type: Interventional

Study phase: Phase 2

Overall status: Active, not recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Neratinib Maleate
Description: - neratinib 240mg po daily - herzuma 8mg/kg (loading) --> 6mg/kg q3w
Arm group label: A arm

Other name: Herzuma

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)

Criteria for eligibility:
Criteria:
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) 5. Alanine aminotransferase (ALT) or aspartate amino transferase (AST) > 3 x upper normal limits (UNL) (in case of liver and bone metastases > 5 x ULN) 6. 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. 8) 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).

Gender: All

Minimum age: 19 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Korea university Guro hospital

Address:
City: Seoul
Country: Korea, Republic of

Start date: June 15, 2021

Completion date: June 30, 2024

Lead sponsor:
Agency: Korea University Guro Hospital
Agency class: Other

Collaborator:
Agency: Korean Cancer Study Group
Agency class: Other

Source: Korea University Guro Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06083662