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

• Status: Active, not recruiting
• Trial end date: 2024-06-30
• Target enrollment: 0
• Participant gender: All

Summary

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

Study drug : neratinib + herzuma (trastuzumab biosimilar)

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Korea University Guro Hospital
• Collaborator: Korean Cancer Study Group
• Treatments: Neratinib

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).