EUCTR2020-005492-12-ES进行中（未招募）1 期
MasterKey-01: A Phase 1/2, Open-label, Two-part, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of BDTX-189, an Inhibitor of Allosteric ErbB Mutations, in Patients with Advanced Solid Malignancies - MasterKey-01
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Histologically- or cytologically-confirmed locally advanced or metastatic solid tumor with documented recurrence or disease progression from standard anticancer therapy in the advanced/metastatic setting;
- •No standard therapy available or standard therapy is considered unsuitable or intolerable according to the Investigator and consultation with the Medical Monitor;
- •Patients with a solid tumor harboring an:
- •a. Allosteric HER2 mutation
- •b. EGFR or HER2 exon 20 insertion mutation
- •as determined by a validated next-generation sequencing (NGS) test routinely used by each institution using tissue and/or plasma. Eligible mutations are summarized in Appendix I.
- •Eligible patients will be assigned to one of the 4 following cohorts:
- •Cohort 1: NSCLC with EGFR or HER2 exon 20 insertion mutation
- •Cohort 2: Breast cancer with an allosteric HER2 mutation and EGFR/HER2 exon 20 insertion mutations
- •Cohort 3: Any tumor (except breast) with an S310F/Y mutation
- •Cohort 4: Any other allosteric HER2 mutation and EGFR/HER2 exon 20 insertion mutations not assigned to Cohorts 1-3;
- •Adequate archival tumor tissue or willing to undergo pretreatment biopsy;
- •Measurable disease according to RECIST version 1.1.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 40
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 60
排除标准
- •Clinical laboratory values meeting the following criteria within 4 weeks (28 days) prior to baseline:
- •a.Serum creatinine =1.5 × upper limit of normal (ULN) or calculated creatinine clearance =60 mL/min using Cockcroft-Gault equation
- •b.Total bilirubin =1.5 × ULN or =3.0 × ULN in the presence of documented Gilbert’s syndrome
- •c.Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) =2.5 × ULN, or AST or ALT =5.0 × ULN in the presence of liver metastases
- •d. Hematologic function:
- •i. Absolute neutrophil count (ANC) =1000 cells/µL
- •ii. Hemoglobin =8.5 g/dL or 5.28 mmol/L
- •iii. Platelet count =75,000/µL
- •Significant cardiovascular disease, including:
- •a. Cardiac failure New York Heart Association Class III or IV, or left ventricular ejection fraction (LVEF) <50% or below the lower limit of the Institution’s normal range
- •b. Myocardial infarction, severe or unstable angina within 6 months prior to baseline
- •c. Significant thrombotic or embolic events within 3 months prior to baseline, including, but not limited to, stroke or transient ischemic attack. Catheter-related thrombosis and deep vein thrombosis are not a cause for exclusion
- •d. History or presence of any uncontrolled cardiovascular disease
- •e. Personal or family history of long QT syndrome
- •Electrocardiogram (ECG) findings obtained using the study site’s ECG machine-derived measurements, meeting any of the following criteria:
- •a. Evidence of second- or third-degree atrioventricular block
- •b. Clinically significant arrhythmia (as determined by the Investigator)
- •c. QTc interval of >470 msec as calculated according to Fridericia’s formula (QTcF = QT/R to R interval0.33)
- •Leptomeningeal or untreated and/or symptomatic central nervous system (CNS) malignancies (primary or metastatic); patients with asymptomatic CNS metastases who have undergone surgery or radiotherapy and who have been on a stable or tapering dose of corticosteroids for at least 2 weeks prior to the first scheduled day of dosing will be eligible for the trial
- •Women who are pregnant or breast-feeding
- •Taking or unable to discontinue proton pump inhibitors within 1 week prior to baseline
- •Known concurrent KRAS mutation
- •Known tumor-harboring resistance mutations including EGFR T790M or C797S mutations or HER2 C805S mutation
- •Prior documented treatment response (i.e., complete response [CR], partial response [PR], or stable disease [SD] lasting =24 weeks by RECIST v1.1) to approved or investigational HER2 or EGFR therapies (e.g., afatinib, lapatinib, dacomitinib,
- •neratinib, trastuzumab deruxtecan, poziotinib, mobocertinib, amivantamab)
- •a. Patients with or without tumor response discontinuing after 8 weeks or less of therapy due to toxicity may be considered after discussion with the Sponsor Medical Monitor
研究者
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