A phase 1 study of TAS0728 in patients with advanced solid tumors with HER2 aberration (TAIBRAKHER study)

未提供0 个研究点目标入组 30 人开始时间: 待定最近更新: 2025年4月10日

试验速览

阶段: 不适用
状态: 招募中
入组人数: 30
主要终点: -

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional
分配方式: Single Arm Study
干预模型: Single Assignment
主要目的: Treatment Purpose
盲法: Open(masking Not Used)

入排标准

年龄范围: 18age old over 至 No limit（—）
性别: All

入选标准

•Patients who are at least 18 years of age at the time of signing the Informed Consent Form (ICF)
•Patients who are diagnosed with a histologically unresectable solid tumor that has received or cannot receive standard treatment
•Has met one of the following criteria for genetic testing:
•a. Has a HER2 mutation if diagnosed with lung cancer;
•b. If diagnosed with a solid tumor other than lung cancer, one of the following;
•i. HER2 immunostaining (IHC) 3+
•ii. HER2 immunostaining (IHC) 2+ and ISH positive for HER2
•iii. HER2 gene mutation
•Evaluable lesions on CT or MRI (measurable lesions are not required)
•ECOG performance status of 0 to
•Has the following laboratory values on examination within 7 days prior to treatment with the investigational drug
•a. Neutrophil count >= 1.5 x 10^9/L (1,500/microL)
•b. Hemoglobin >= 8.0 g/dL
•c. Platelet count >= 75 x 10^9/L (75,000/microL)
•d. Albumin >= 3 g/dL
•e. Serum potassium, magnesium, phosphorus, sodium, and total calcium levels within institutional reference values
•f. AST and ALT <= 3.0 x ULN (<= 5.0 x ULN if liver function is abnormal due to liver metastases)
•g. Serum total bilirubin <= 1.5 x ULN
•h. Serum creatinine <= 1.4 x ULN or creatinine clearance (CrCl) >= 50 mL/min
•i. For calculated values, CrCl is calculated using the following Cockcroft-Gault equation
•ii. CrCl for men = (140 - age) x weight [kg] / [72 x serum creatinine (mg/dL)
•iii. CrCl for women = CrCl for men x 0.85
•iv. If urine is stored for 24 hours, use the measured value.
•Corrected QT using Fridericia formula (QTcF) < 450 ms (< 470 ms for women)
•Left ventricular ejection fraction (LVEF) on echocardiography or multigate scan (MUGA) > the lower limit of the institutional reference value (> 50% if no institutional reference value)
•Negative for hepatitis B virus surface (HBs) antigen and HBs antibody or hepatitis B virus core (HBc) antibody (however, patients who are HBs or HBc antibody positive and hepatitis B virus [HBV] DNA negative may be registered)
•Negative for hepatitis C virus (HCV) antibodies (however, patients who are positive for HCV antibodies and negative for HCV RNA may be enrolled)
•Recovery of previously treated side effects (except alopecia, hyperpigmentation, and anemia) to Grade 1 or less
•Patients who are eligible for oral administration of drugs
•Expected to survive more than 12 weeks
•Male and/or female
•Capable of giving signed informed consent as described in the informed consent form and in the protocol.

排除标准

•Any of the following cardiac dysfunction or clinically significant cardiac disease
•a. Symptomatic chronic heart failure (NYHA classes II-IV) or previous or concurrent arrhythmia requiring treatment
•b. Previous or concurrent myocardial infarction or angina pectoris
•c. Uncontrolled hypertension
•d. Clinically significant valvular heart disease
•e. Suspected or previous/complicated Brugada syndrome
•f. Conditions that may result in drug-induced QT prolongation
•i. Congenital or acquired QT prolongation syndrome
•ii. Family history of sudden death
•iii. History of drug-induced
•iv. Concomitant use of medications associated with QT prolongation (e.g., imipramine, mozide, quinidine, procainamide, disopyramide)
•Any of the following treatment within the defined time period prior to the investigational drug administration.
•a. Extensive surgery within 4 weeks (28 days) prior to study drug administration (surgical wounds must have completely healed prior to the first dose of study drug)
•b. Extensive radiation therapy within 4 weeks prior to study drug administration or local radiation therapy within 2 weeks prior to first dose of study drug
•c. Local treatment within 4 weeks prior to study drug administration [transarterial chemoembolization (TACE), selective internal radiation therapy (SIRT), or ablation, etc.]
•d. Anticancer therapy within 2 weeks (14 days) prior to study drug administration (within the past 5 weeks for mitomycin). molecular-targeted agents or immunotherapy, not more than 2 weeks or 5 times the half-life (whichever is shorter)
•e. Other investigational agents being administered or within 3 weeks prior to administration of the investigational agent in this study
•Has any clinically significant acute or chronic medical or psychiatric condition of any clinical significance that may increase the risk associated with the administration of the investigational drug or that may affect the interpretation of study results, or any laboratory abnormalities, including but not limited to
•a. Brain metastases (not including primary brain tumors) that have not been clinically stable for at least 2 months after steroid withdrawal
•b. Soft tissue metastases
•c. Acute systemic infection
•d. Diarrhea or vomiting regardless of severity
•e. Moderate or greater nausea
•f. Severe chronic renal disease
•g. A history of interstitial lung disease requiring steroid therapy or complications of such disease
•h. Liver disease, including non-compensated liver disease
•i. Life-threatening autoimmune disease
•j. Other severe acute or chronic medical symptoms or mental status or laboratory abnormalities that, in the judgment of the investigator, would make the subject ineligible for enrollment in this study
•Chronic pulmonary dysfunction or pleural effusion (malignant or benign) requiring chronic oxygen therapy
•Poorly controlled pleural effusion or ascites.
•Has a serious gastrointestinal disorder that may cause gastrointestinal perforation
•Has a gastrointestinal disorder that may affect absorption of oral drugs, or has undergone surgery or treatment of the gastrointestinal system
•Other exclusion criteria
•judged by the investigator to be unsuitable as a patient for this study
•Pregnant or lactating patient. However, if lactation is discontinued ( not resumed), the patient can be enrolled.
•Lung cancer patients with a history of prior HER2 tyrosine kinase inhibitor treatment in the dose escalation part (participation in the dose escalation part is not excluded)
•Patients with a history of hypersensitivity to any component of the investigational drug
•Patients requiring continuation of strong CYP3A inhibitor or inducer

结局指标

主要结局

Dose escalation part -Dose Limiting Toxicity Dose expansion part - Adverse event

次要结局

未报告次要终点

研究者

发起方

未提供

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