NCT06015503进行中（未招募）2 期
A Phase Ⅱ,Open-label, Single-line, Multiple Cohorts, Multicenter Study Assessing the Safety and Efficacy of PLB1004 in EGFR ex20ins Mutation Patients With Advanced and Metastatic Non-small Cell Lung Cancer(NSCLC)
Avistone Biotechnology Co., Ltd.1 个研究点 分布在 1 个国家目标入组 139 人开始时间: 2023年7月21日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 139
- 试验地点
- 1
- 主要终点
- objective Response Rate (ORR)
研究概览
简要总结
It is a phase Ⅱ,open-label, single-line, Multiple cohorts, Multicenter study assessing the Safety and Efficacy of PLB1004 in EGFR ex20ins mutation patients with Advanced and Metastatic Non-small Cell Lung Cancer(NSCLC).
详细描述
This a three-stage study consist a Screening Phase (Day -28 to -1), a Treatment Phase (until treatment discontinuation), and a Follow-up Phase (including end of treatment visit (EOT),end of study visit(EOS), safety follow-up and survival follow-up).
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability to understand and willingness to sign a written informed consent document.
- •Aged at least 18 years old.
- •Histologically or cytologically confirmed locally advanced or metastatic NSCLC (stage IIIB~IV).
- •According to the prior treatments having received for advanced disease (platinum containing or/and immunotherapy containing systemic therapy, not more than three lines), participants were divided into two cohorts。
- •Participants with EGFR ex20ins mutation.
- •ECOG performance status 0 to
- •Life expectancy is not less than 12 weeks.
- •At least one measurable lesion as defined by RECISTV1.
- •Participants must have specific organ and bone marrow function.
排除标准
- •Exclusion
- •Having the anticancer therapy prior to the first dose of PLB1004 as follows:
- •Any monoclonal antibodies targeting EGFR/HER2/VEGFR within 4 weeks.
- •Any cytotoxic drugs or other anticancer drugs from a previous treatment regimen within 14 days.
- •Any anticancer herbal medicine within 7 days
- •Major surgery within 4 weeks prior to starting PLB1004 or who have not recovered from side effects of such procedure except for the biopsy of Thoracoscopy and the clinical test of Mediastinoscopy could ≤ 7 days prior to starting PLB1004..
- •Radiotherapy to lung fields and whole-brain fields ≤4 weeks prior to starting PLB
- •For all other anatomic sites, radiotherapy ≤2 weeks prior to starting PLB1004 or patients who have not recovered from radiotherapy-related toxicities. Palliative radiotherapy for bone lesions is not included.
- •Any anti-EGFR TKI for the EGFR ex20ins mutation.
- •Any third-generation anti-EGFR TKI during the treatment having achieved a best overall response of the partial response or complete response.
- •Had not recovered from the adverse events and comorbidities caused by prior Systemic chemotherapy ,surgery ,radiotherapy to ≤ Grade 1（except for hair loss and permanent radiotherapy damage ）,the neurological toxicity caused by platinum could ≤ Grade
- •Patients receiving treatment with medications that meet one of the following criteria and that cannot be discontinued at least 1 week prior to the start of treatment with PLB1004 and for the duration of the study:
- •Strong inhibitors of CYP3A4
- •Strong inducers of CYP3A4
- •metformin a MATE transporter substrate
- •Patients with spinal cord compression ,brain membrane metastasis and symptomatic central nervous system (CNS), who are neurologically unstable or have required increasing doses of steroids within the 2 weeks prior to study manage CNS symptoms.
- •Patients with uncontrolled and symptomatic pleural effusions, peritoneal effusions and pericardial effusions within 4 weeks prior to the start of treatment with PLB
- •Presence or history of a malignant disease other than NSCLC that has been diagnosed and/or required therapy within the past 3 years. Exceptions to this exclusion include the following: completely resected basal cell and squamous cell skin cancers, indolent malignancies that currently do not require treatment, and completely resected carcinoma in situ of any type.
- •Past medical history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease.
- •Konwn positive hepatitis B (hepatitis B virus , HBV) surface antigen(HBsAg) and HBV-DNA test value≥ULN.
- •known positive hepatitis C antibody(anti-HCV) and Anti-HIV(+).Note: Subjects with a prior history of HCV, who have completed antiviral treatment and have subsequently documented HCV RNA below the lower limit of quantification per local testing are eligible.
- •Having significant or uncontrolled systemic disease, including but not limited to:
- •Poorly controlled hypertension (referring to systolic blood pressure>100 mmHg after treatment) .
- •Ongoing or active infection.
- •Keratitis or onset of ulcerative keratitis.
- •Other significant disease, mental illness or laboratory abnormalities that could affect the compliance of the patient on the protocol or investigator's judgement.
- •Clinically significant, uncontrolled heart disease, including but not limited to:
- •Abnormal QT interval on screening electrocardiogram (ECG), defined as the average value of triplicate QTcF>470ms.
- •Have significant arrhythmias such as ventricular arrhythmia, supraventricular arrhythmia which could not be controlled by drugs, nodal arrhythmia and other cardiac arrhythmias which could not be controlled by drugs, Grade≥3 of Congestive heart failure by the New York Heart Association (NYHA).
- •Any factors that increase the risk of QTc interval prolongation, such as hypokalemia, genetic long QT syndrome, taking drugs that causing the QT interval prolongation.
- •Medical history of deep vein thrombosis or pulmonary embolism within 6 months prior to enrolment or any of the following: Myocardial infarction, unstable angina, stroke, transient ischemic attack, coronary/peripheral artery bypass graft, or any acute coronary syndrome. Or bleeding tendencies or hypercoagulable coagulopathy within 6 months prior to first dose.
- •Have active digestive system disease, or major gastrointestinal surgery which may significantly affect the taking or absorption of PLB1004(such as ulcerative lesions, uncontrollable nausea, vomiting, diarrhea, and malabsorption syndrome).
- •History of hypersensitivity to active or inactive excipients of PLB1004 or drugs with a similar chemical structure of class to PLB
- •pregnant or nursing women.
- •Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements.
研究组 & 干预措施
PLB1004
Experimental
PLB1004 given alone as monotherapy
干预措施: PLB1004 (Drug)
结局指标
主要结局
objective Response Rate (ORR)
时间窗: 3 years
To evaluate the Objective Response Rate（ORR）which is defined by IRC as the proportion of subjects with confirmed best overall response of complete response or partial response per RECIST v 1.1.
次要结局
- Disease Control Rate ( DCR)(3 years)
- Duration of Response (DOR)(3 years)
- Intracranial Overall Response Rate（ORR）(3 years)
- Intracranial Disease Control Rate (DOR)(3 years)
- objective Response Rate (ORR)(3 years)
- Intracranial Disease Control Rate (DCR)(3 years)
- Area Under the Curve（AUC0-t）of PLB1004(Time Frame: Up to approximately 28 days; pre-dose and multiple time points post-dose)
- Apparent clearance (CL/F) of PLB1004(Time Frame: Up to approximately 28 days; pre-dose and multiple time points post-dose)
- Overall Survival (OS)(3 years)
- Intracranial Progression-Free Survival (PFS)(3 years)
- Incidence of Treatment-Emergent Adverse Events (TEAEs)(2 years)
- Area Under the Curve（AUC0-∞）of PLB1004(Time Frame: Up to approximately 28 days; pre-dose and multiple time points post-dose)
- Progression-Free Survival (PFS)(3 years)
- Incidence of abnormalities in Clinical Laboratory Assessments.(2 years)
- Incidence of abnormalities in Vital Signs.(2 years)
- Maximum plasma concentration (Cmax) of PLB1004(Time Frame: Up to approximately 28 days; pre-dose and multiple time points post-dose)
- Time to maximum plasma concentration (Tmax) of PLB1004(Time Frame: Up to approximately 28 days; pre-dose and multiple time points post-dose)
- Half-life time (t1/2) of PLB1004(Time Frame: Up to approximately 28 days; pre-dose and multiple time points post-dose)
研究者
研究点 (1)
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