NCT06083662已完成2 期
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
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- overall response rate (ORR)
研究概览
简要总结
Prospective, Basket, Open-label, Multi-dose, Single-arm, Simon's two-stage, Multi-center trial
Study drug : neratinib + herzuma (trastuzumab biosimilar)
详细描述
- Primary objective Evaluate overall response rate (ORR) in HER2 mutated advanced solid cancer patients based on RECIST v1.1
- 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
- Evaluate the overall safety of the test drug
- Evaluate the predefined adverse event (diarrhea)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •Eastern Cooperative Oncology Group (ECOG) performance status 0~
- •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.
排除标准
- •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
- •Inadequate organ functions:
- •Hemoglobin (Hemoglobin) < 8 .0g / dL
- •Absolute neutrophil count (ANC) <
- •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).
研究组 & 干预措施
A arm
Experimental
Neratinib + herzuma
干预措施: Neratinib Maleate (Drug)
结局指标
主要结局
overall response rate (ORR)
时间窗: at 6 months
ORR according to RECIST v1.1
次要结局
- 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)
研究者
Park, In Hae
MD, PhD
Korea University Guro Hospital
研究点 (1)
Loading locations...
相似试验
已完成
2 期
Azacitidine, Lenalidomide and DLI as Salvage Therapy for MDS, CMML and sAML Relapsing After Allo-HSCTLeukemia, Myeloid, AcuteMyelodysplastic SyndromesLeukemia, Myelomonocytic, ChronicNCT02472691Heinrich-Heine University, Duesseldorf50
Unknown
2 期
Safety and Efficacy of Therapeutic Hepatitis B Adenovirus Injection (T101) Combined With Nucleoside (Acid) Analogues in Chronic Hepatitis B PatientsHepatitis B Virus (HBV)NCT04189276Tasly Tianjin Biopharmaceutical Co., Ltd.100
招募中
2 期
NB02 (Poseltinib) Combined Rituximab and Lenalidomide in R/R PCNSLPrimary CNS Lymphoma (PCNSL)NCT06737250NOBO Medicine33
已完成
2 期
Study of a Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) Virus-like Particle (VLP) VaccineCovid19NCT04962893Ihsan GURSEL, PhD, Prof.349
已完成
2 期
A Study for Safety and Efficacy Evaluation of Various Doses of STP705 in Reducing Keloid RecurrenceKeloidNCT04844840Sirnaomics29