An Open-Label, Multi-Center, 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
- Conditions
- Neoplasms
- Registration Number
- KCT0006038
- Lead Sponsor
- Koera University Guro Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 42
1) Patients who voluntarily decide to participate and give written consent after hearing the description of the characteristics of the clinical trial and investigational drugs
2) Adult men and women over 19 years old
3) Histologically or cytologically confirmed advanced solid cancer patient, when HER2 hot spot mutation is confirmed in tumor tissue or tumor DNA (cell free tumor DNA, ctDNA) in blood as a result of K-master panel test
4) Patients with at least one measurable lesion according to RECIST v 1.1
5) Eastern Cooperative Oncology Group (ECOG) performance status is 0~2
6) Patients whose life expectancy is more than 6 months
7) Patients with more than one line of standard treatment who no longer have an effective treatment, or metastatic/progressive solid cancer patients who are judged by their doctor to be helpful with HER2 mutation targeted therapy.
8) Patients who have agreed to provide plasma/blood samples for the most recent metastatic/progressive tumor sample or new tumor biopsy for gene sequencing and other biomarker analysis.
1) Patients who received radiotherapy or surgical treatment within 2 weeks
2) If there is a brain metastasis that requires treatment with symptoms, however, registration is possible if it is stable without steroid treatment after treatment for brain metastasis.
3) In case of unsuitable HER2 mutation (non-hot spot mutation, subclonal mutation, premature stop codon or frame shift mutation):
4) If you cannot swallow tablets or do not have a doctor
5) If the toxicity of the previous treatment has not recovered to the baseline level or below Grade 1
? However, not applicable in the following cases.
(1) Inspection items separately defined in the selection criteria
(2) Vitiligo or alopecia
(3) When the investigator evaluates that the toxicity observed at the baseline is irreversible and will not be aggravated by administration of the investigational drug.
(4) When the tester evaluates that toxicity of Grade 2 or higher is controlled by appropriate adjuvant drug treatment.
6) If the screening clinical laboratory test results are as follows:
(1) Hemoglobin less than 8.0g/dL (transfusion and other treatments allowed until the test value is reached)
(2) Absolute neutrophil count (ANC) less than 1.0x10³per mm³
(3) Platelet count less than 100x10?/L (100,000/mm³)
(4) Total bilirubin exceeds the normal upper limit (UNL) 1.5 times (*Gilbert's syndrome not applicable)
(5) Alanine aminotransferase (ALT) or aspartic acid aminotransferase (AST) 3 times higher than normal upper limit (UNL) (*>5xULN in case of liver and bone metastasis)
(6) Above the normal upper limit of creatinine in blood (UNL) 1.5 times or less than eGFR 30 mL/min/1.73 m²
7) Left ventricular contracture rate is less than 50% by multi-gate acquisition scan (MUGA) or echocardiography
8) Significant chronic gastrointestinal disorders with diarrhea as the main symptom (eg, Crohn's disease, malabsorption, or diarrhea of ??any etiology of grade 2 or higher according to NCI CTCAE version 5.0 is present at baseline).
9) Uncontrolled concomitant diseases including:
(1) Cardiomyopathy, a history of symptomatic congestive heart failure (NYHA Class II-IV)
(2) Myocardial infarction within 12 months of enrollment or a history of unstable angina with a new drug administration or change in dose within 6 months
(3) Patients with clinically significant arrhythmia who have difficulty participating in clinical trial
(4) Other cardiovascular diseases that are judged to be difficult to participate in clinical trials
(5) Patients with previously known severe renal impairment (renal failure, patients undergoing renal dialysis, etc.)
(6) Patients with severe hepatic impairment known in the past (liver lesions, etc.)
(7) Blood coagulation disorder that is considered difficult to participate in clinical trials
(8) Patients who have difficulty breathing or need oxygen supplementation during severe stabilization due to advanced malignancies
10) Patients with the following clinically active infections
(1) Hepatitis B (only HBs Ag as a screening test; if necessary, positive for IgM anti-HBc, HBV NAT tests)
(2) Hepatitis C (Anti-HCV only as a screening test; however, anti-HCV positive may participate if HCV RNA is negative in NAT test)
(3) HIV infection (Only Anti-HIV is performed as a screening test)
(4) Other active infections or unexplained fever >38.5°C (101.3°F) that are considered difficult to participate in the clinical trial
11) Subjects contraindicated for both M
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method PFS, Progression Free Survival
- Secondary Outcome Measures
Name Time Method BORR, Best Objective Response Rate