NCT05055518暂停1 期
Phase I Study on Safety, Tolerance, and Pharmacokinetics of APL-102 Capsule in Patients With Advanced Solid Tumors
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 暂停
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- DLT
研究概览
简要总结
This study will evaluate the safety and tolerability of APL-102 Capsule and characterize the pharmacokinetic (PK) profile in advanced solid tumor patients.
详细描述
This study is an open, multicenter dose-escalation study to evaluate the safety and tolerance of APL-102 and obtain the relevant data of APL-102 in patients with advanced solid tumors. In the dose escalation stage, based on the incidence of dose limited toxicity (DLT) and adverse event (AE), explore and determine the maximum tolerated dose (MTD) and phase II recommended dose (RP2D). After RP2D and administration protocol are determined, an extended study will be conducted on 6-10 subjects to further evaluate the safety and antitumor activity of APL-102.
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
- •Male or female, age ≥ 18 and ≤ 75 years old.
- •Patients with unresectable or metastatic advanced solid tumors confirmed by histology or cytology, and after the failure of standard treatment, or cannot tolerate standard treatment, or have no standard treatment.
- •There were measurable lesions according to the efficacy evaluation criteria of solid tumors (RECIST version 1.1).
- •Eastern Cooperative Oncology Group(ECOG) performance status score is 0 to
- •Life expectancy is more than 3 months after the first administration.
- •The organ function level must meet the following requirements:
- •Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤ 2.0× upper limit of normal value (ULN) (patients with liver metastasis≤ 5 × ULN). Serum bilirubin ≤ 1.5×ULN (total bilirubin ≤ 3×ULN in patients with Gilbert syndrome). Absolute neutrophil count ≥ 1.5×10^9/L. Platelet count ≥ 100×10^9/ L. Hemoglobin ≥ 9 g / dL.
- •No other chemotherapy was received within four weeks before the first administration of the trial; All previous anti-tumor treatments, including targeted therapy and endocrine therapy, shall pass through at least five half-lives (or no more than 28 days) after receiving targeted therapy/endocrine therapy, and patient shall recover to the standard level specified in the test from the toxic reaction of the treatment.
- •For patients who have received radiotherapy for spine and/or peripheral limbs, they can only be enrolled after four weeks and two weeks before the first administration and should recover from the toxic reaction of treatment to the standard level specified in the study.
- •No major surgery was performed within four weeks before the first administration of APL-102., etc.
排除标准
- •In addition to the malignancies in the study, patients with systemic diseases leading to poor medical risk (such as uncontrollable infection in the active phase).
- •Life-threatening diseases, severe organ dysfunction, interference with the absorption or metabolism of APL-102, or other reasons that the researchers believe may endanger the safety of subjects or affect the integrity of research results.
- •Patients with a history of heart disease or potential risk of heart disease.
- •Patients with low circulatory function as defined by the New York Heart Association's (NYHA) functional criteria.
- •Patients with a definite diagnosis of chronic obstructive pulmonary disease, bronchial asthma or interstitial lung disease, or patients with forced expiratory volume in one second/ forced vital capacity (FEV1/FVC) ratio < 70% in pulmonary function test.
- •Patients with decompensated cirrhosis or history of allogeneic bone marrow transplantation or organ transplantation.
- •Patients in repeated resting states during screening had mean systolic blood pressure ≥140 mmHg, diastolic blood pressure ≥90 mmHg, or positive proteinuria (allowing antihypertensive agents to control blood pressure).
- •Have a history of human immunodeficiency virus (HIV) infection or HIV antibody positive; or seropositive results consistent with active infection for hepatitis B virus (in case of only hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive, the examination of Hepatitis B (HBV) DNA copy number is needed: HBV DNA copy number must not exceed 1,000 copies/mL or 200 IU/mL.) or hepatitis C virus.
- •Patients with the symptomatic primary brain tumor and/or secondary brain metastasis, uncontrollable antiepileptic drugs and requiring high-dose steroid treatment. Or cerebrovascular accident, transient ischemic attack, or intermittent claudication within six months before treatment.
- •Pregnant or lactating patients., etc.
研究组 & 干预措施
A Phase I, open-labeled multicenter study
Experimental
APL-102 Capsules
干预措施: APL-102 Capsules (Drug)
结局指标
主要结局
DLT
时间窗: 36 days
Dose limiting toxicities
Adverse Events (AEs)
时间窗: From time of informed consent signature to 30 days after the subject's last visit (approximately 1 year)
Adverse events occurred in all subjects during the study treatment according to the National Cancer Institute Common Terminology Standard for adverse events (NCI CTCAE) standard version 5.0
次要结局
- Objective response rate(ORR)(Approximately 1 year)
- Incidence of Adverse Events(From time of informed consent signature to 30 days after the subject's last visit (approximately 1 year))
- Progression-free survival(PFS)(Approximately 1 year)
- Duration of response(DOR)(Approximately 1 year)
- Overall survival(OS)(Approximately 1 year)
- Peak plasma concentration (Cmax)(36 days)
- Time to reach Cmax (Tmax)(36 days)
- The area under the plasma concentration-time curve from time zero to the last measurable time point (AUC0-t)(36 days)
研究者
研究点 (1)
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