NCT05117658Unknown2 期
A Single-Arm, Multi-Centre, Open-Label Phase II Study of HA121-28 in Patients With RET Fusion-Positive Advanced Non-Small Cell Lung Cancer
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.1 个研究点 分布在 1 个国家目标入组 83 人开始时间: 2022年2月18日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 83
- 试验地点
- 1
- 主要终点
- Objective Response Rate (ORR)
研究概览
简要总结
This study is a multicenter, open-label, single-arm phase II study to evaluate efficacy and safety of HA121-28 tablets in patients with rearranged during transfection (RET) fusion-positive advanced non-small cell lung cancer (NSCLC).
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntarily participate in this study and sign the informed consent form;
- •Aged 18 ~ 75 years old (inclusive), male or female;
- •Patients with histologically or cytologically confirmed unresectable locally advanced or metastatic non-small cell lung cancer;
- •RET gene fusion, as demonstrated by "Next-generation" sequencing(NGS) method in central laboratory with College of American Pathologists(CAP) or Clinical Laboratory Improvement Amendments(CLIA) certification;
- •Progressive disease after at least one line of standard therapy (including patients with disease progression during or within 6 months of the end of adjuvant therapy);
- •At least one measurable lesion according to RECIST 1.1 (for lesions previously treated with radiation, the lesion can be included as a measurable lesion only if there is clear disease progression after radiotherapy);
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) score 0-1;
- •Adequate organ function, laboratory tests meeting the following criteria:
- •Neutrophil count (ANC) ≥ 1.5 × 10^9/L (no G-CSF for WBC-elevating therapy within 2 weeks prior to the laboratory test);
- •Platelet count (PLT) ≥ 75 × 10^9/L (no platelet transfusion or other drugs to promote platelet production within 2 weeks prior to the laboratory test);
- •Hemoglobin (Hb) ≥ 90 g/L; (not receiving red blood cell transfusion or erythropoiesis-stimulating drugs within 2 weeks prior to the laboratory test);
- •Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × upper limit of normal (ULN) (≤ 5.0 × ULN for patients with liver metastases);
- •Serum total bilirubin (TBIL) ≤ 1.5 × ULN;
- •Serum creatinine ≤ 1.5 × ULN;
- •Albumin ≥ 30 g/L;
- •Male and female patients of childbearing age agree to take effective contraceptive measures during treatment and within 6 months after the completion of treatment.
排除标准
- •Had a documented oncogenic driver gene alteration other than RET in NSCLC, ie, activating EGFR, BRAF, or KRAS mutation, MET exon 14 skipping mutation or high-level amplification, and ALK, ROS1, or NTRK1/2/3 gene fusions;
- •Prior treatment with selective RET inhibitors (including investigational selective RET inhibitors, such as LOXO-292, BLU-667, RXDX-105, etc.);
- •Patients who previously received any anti-tumor therapy (including but not limited to chemotherapy, radiotherapy and targeted therapy, etc.) within 4 weeks before the first use of the study drug; traditional Chinese medicine or Chinese patent medicine with anti-tumor indications within 2 weeks; local palliative radiotherapy for the relief of bone metastasis pain within 2 weeks;
- •Abnormal coagulation function (INR > 1.5 or APTT > 1.5 × ULN); patients with bleeding tendency (such as active peptic ulcer) or receiving thrombolytic or anticoagulant therapy;
- •Urine routine showed urine protein ≥ + + and 24 h urine protein > 1.0 g;
- •Patients who have undergone major surgical procedures within 4 weeks before the first dose or are expected to undergo major surgery during the study;
- •Patients with central nervous system (CNS) metastases who present with progressive neurological symptoms or require an increase in corticosteroid dose to control their CNS disease. If a patient requires treatment with corticosteroids for CNS disease, the dose must be stable for two weeks prior to the first dose;
- •Presence of poorly controlled pericardial, pleural, or peritoneal effusion;
- •Interstitial pneumonia requiring steroid therapy, drug-induced pneumonitis, radiation pneumonitis (except for stable radiation pneumonitis);
- •Significant cardiovascular disease, such as heart failure greater than New York Heart Association (NYHA) Class 2, unstable angina, serious arrhythmia, myocardial infarction or stroke within 6 months prior to the first dose, poorly controlled hypertension (defined as systolic blood pressure > 150 mmHg or diastolic blood pressure > 100 mmHg on multiple measurements while on medication);
- •Patients who met any of the following criteria will be excluded:
- •QT interval (QTcF) value ≥ 470 ms for females and ≥ 450 ms for males; or congenital long QT syndrome, taking drugs known to prolong QT interval, family history of long QT syndrome;
- •Resting ECG showed any clinically significant abnormalities in rhythm, conduction, or morphology that required clinical intervention;
- •Cardiac ejection fraction less than 50%;
- •Patients with active hepatitis B virus or hepatitis C virus infection:
- •HBsAg positive with HBV DNA higher than the upper limit of normal range of the study site;
- •HCV antibody positive with HCV RNA higher than upper limit of normal range of the site;
- •Human immunodeficiency virus infected (HIV positive);
- •Inability or severe dysphagia;
- •Patients who have suffered from or are complicated with any other malignant tumor within 5 years (except radically resected skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, local prostate cancer, in situ cervical cancer or other carcinoma in situ);
- •Presence of any severe and/or uncontrolled disease that may affect the drug evaluation in the judgment of the investigator, including but not limited to: life-threatening autoimmune system diseases; drug abuse; severe nervous system diseases (such as epilepsy, dementia, etc.); history of severe mental disorders; severe infection, etc.;
- •Pregnant or lactating women;
- •Other conditions that, in the opinion of the investigator, make participation in the study unsuitable.
研究组 & 干预措施
HA121-28
Experimental
Patients will receive HA121-28 tablets at 450 mg once daily (QD) for 21 days on a 28-day treatment cycle.
干预措施: HA121-28 tablet (Drug)
结局指标
主要结局
Objective Response Rate (ORR)
时间窗: Up to approximately 12 months
The percentage of patients who achieve a complete response (CR) or partial response (PR) evaluated by Independent Review Committee (IRC) according to RECIST 1.1.
次要结局
- ORR(Up to approximately 12 months)
- Progression-Free Survival (PFS)(Up to approximately 12 months)
- PFS(Up to approximately 12 months)
- Duration of Response (DOR)(Up to approximately 12 months)
- DOR(Up to approximately 12 months)
- Incidence of treatment-related adverse events (AEs) and serious adverse events (SAEs).(Up to 28 days after the last administration of HA121-28)
- Overall survival (OS)(Up to approximately 24 months)
- DCR(Up to approximately 12 months)
- Disease Control Rate (DCR)(Up to approximately 12 months)
研究者
研究点 (1)
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