A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of KL340399 Intratumoral in Patients With Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Maximum Tolerated Dose (MTD)
研究概览
简要总结
This is a single center, open-label, dose increasing study to evaluate the safety, tolerability, pharmacokinetic(PK) profile, and antitumor efficacy of KL340399 intratumoral in patients with advanced solid tumors.
详细描述
This is a single center, open-label, dose increasing study to evaluate the safety, tolerability, pharmacokinetic(PK) profile, and antitumor efficacy of KL340399 intratumoral in patients with advanced solid tumors.The dose increasing method of "BLRM" is used to explore the safety, tolerance and determine the maximum tolerated dose(MTD).
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
- •Patient is at least ≥18 years of age (male or female);
- •Patients with histologically and/or cytologically confirmed advanced solid tumors who have failed standard of care, or who have no available standard of care regimen, or who are unqualified for standard of care. Presence of at least one measurable lesion for intratumoral ;
- •Eastern Cooperative Oncology Group (ECOG) score of 0 or 1, estimated survival ≥ 3 months;
- •Adequate organ and bone marrow function (no blood components and cytokines are allowed within 14 days prior to the first dose) ;
- •More than 4 weeks from the last radiotherapy, chemotherapy, surgery, hormone treatment, target therapy, and toxicity from previous antitumor therapy returned to baseline or CTCAE≤ grade 1;
- •Patients of childbearing potential (male or female) must use effective medical contraception during the study and for 3 months after the end of dosing;
- •Patients voluntarily participate in the study, sign the ICF, and will be able to comply with the protocol-specified visits and relevant procedures.
排除标准
- •Known history of severe allergies, or allergy to any component of KL340399;
- •Received any previous therapy of STING-activating, or received any immunostimulant therapy within 28 days;
- •Have other malignancies within 5 years;
- •Concomitant or known metastases to brain or central nervous system;
- •Active autoimmune disease;
- •History of major cardiovascular diseases;
- •Uncontrolled systemic diseases;
- •Known of coagulation disorders, hemorrhagic disease;
- •Confirmed serious lung disease or lung disease;
- •Subjects with third space fluid that can not be controled by drainage or other methods;
- •Known active infection;
- •Known HIV, active hepatitis B/C virus;
- •Pregnant or lactating women;
- •Received immunotherapy and had immune related adverse reactions ≥ grade 3;
- •Have received stem cell transplantation or organ transplantation;
- •Receive any live or attenuated live vaccine within 4 weeks;
- •History of serious dementia, altered mental status, or any psychiatric disorder;
- •Evidence of alcohol or drug abuse;
- •Participated in any other clinical trials and received treatment within 4 weeks;
- •Have other factors based on which the investigator considers that the subjects are not appropriate to participate in the study.
研究组 & 干预措施
Dose Escalation
KL340399 weekly on Days 1, 8 and 15 on repeated 21-day cycles in escalating doses.
干预措施: KL340399 Intratumoral (Drug)
结局指标
主要结局
Maximum Tolerated Dose (MTD)
时间窗: From data of initial dose until up to 21 days for treatment
The maximum tolerated dose (MTD) is refers to the highest dose at which the patient's DLT incidence exceeding 33% during the first cycle.
Number of subjects achieving Dose-limiting toxicity (DLT)
时间窗: From data of initial dose until up to 21 days for treatment
DLT is defined as an adverse event (AE) that meets protocol defined DLT criteria during cycle 1 and is at least possibly related to study drug.
Incidence of Adverse Events [Safety and Tolerability]
时间窗: Up to 24 months
Incidence of adverse events of KL340399 as a monotherapy as determined by patient reporting, clinical laboratory test changes from baseline, and clinically significant changes in physical examination data.
Recommended Phase 2 Dose (RP2D)
时间窗: Up to 24 months
The recommended phase 2 dose (RP2D) will be based on a consideration of the totality of data including but not limited to safety data (including DLTs), PK, PD and preliminary efficacy, as available.
次要结局
- Objective Response Rate (ORR)(Up to 24 months)
- Progression Free Survival (PFS)(Up to 24 months)
- Overall Survival (OS)(Up to 24 months)
- Duration of Response (DOR)(Up to 24 months)