NCT06868199招募中1 期
A Phase I/II, First-in-Human (FIH), Open-Label, Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of LM-168 as a Single Agent or in Combination With Toripalimab in Subjects With Advanced Solid Tumours
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 87
- 试验地点
- 6
- 主要终点
- Temperature (Celsius)
研究概览
简要总结
For phase I ,this study is to assess the safety and tolerability, obtain the recommended phase 2 dose (RP2D) and/or Maximum Tolerated Dose (MTD) for LM-168 as a single agent or in combination with toripalimab in subjects with advanced solid tumours.
For phase II ,this study is to assess the preliminary anti-tumour activity of LM-168 as a single agent or in combination with toripalimab measured by objective response rate (ORR) in subjects with advanced solid tumours.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
- •Subjects who are willing to participate in the study and sign the informed consent form (ICF) prior to any procedure.
- •Aged ≥18 years old (including boundary values) , male or female.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-
- •Life expectancy ≥ 3 months.
- •In dose escalation stage, subjects must have histological or cytological confirmation of recurrent or refractory advanced solid tumours, and have progressed on standard therapy, or are intolerable for available standard therapy, or there is no available standard therapy.
- •In dose expansion stage, subjects must have histological or cytological confirmation of selected advanced solid tumors.
- •Pre-treatment archived tumour tissue or on-treatment tumour biopsy could be provided for biomarker analysis optionally.
- •At least one measurable disease.
- •Subjects must show appropriate organ and marrow function in laboratory examinations within 7 days prior to the first dose.
- •Subjects who are able to communicate well with investigators and understand and adhere to the requirements of this study.
排除标准
- •Participate in any other clinical trial within 28 days prior to 1st dosing of LM-
- •Having received prior anti-CTLA-4 or any other immunotherapy or immune-oncology (IO) agent within 28 days of commencing treatment with LM-168 or experienced a toxicity that led to permanent discontinuation of prior immunotherapy.
- •Subjects who have received the anti-tumor treatments within the specified time periods prior to the first dosing of LM-
- •Any adverse event from prior anti-tumour therapy has not yet recovered to ≤ grade 1 of CTCAE v5.
- •Subjects with uncontrolled tumour-related pain.
- •Subjects with known central nervous system (CNS) or meningeal metastasis.
- •Subjects who have uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures.
- •Subjects with esophageal or gastric varices requiring immediate intervention, or those with a history of variceal bleeding.
- •Hepatic encephalopathy, hepatorenal syndrome, Child-Pugh class B or more severe liver cirrhosis.
- •Tumor invasion of surrounding vital organs or a risk of developing esophagotracheal fistula or esophagopleural fistula.
- •Patients with a history of active or previously confirmed inflammatory bowel disease.
- •Subjects who experienced grade 3 or higher hypersensitivity to the treatment that contains monoclonal antibody.
- •Subjects who previously experienced grade ≥ 3 immune-related adverse events during immunotherapy, as well as subjects who discontinued prior immunotherapy due to severe or life-threatening immune-related adverse events.
- •Subjects who take systemic corticosteroids (> 10 mg daily prednisone equivalents) or other systemic immunosuppressive medications within 2 weeks prior to the first dosing of LM-
- •Subjects with the known history of autoimmune disease.
- •Subjects with the history of idiopathic pulmonary fibrosis, organizing pneumonia , drug-induced pneumonitis, idiopathic pneumonitis, interstitial lung disease, severe radiation pneumonitis or evidence of active pneumonitis on screening chest CT scan.
- •Use of any live attenuated vaccines within 28 days prior to 1st dosing of LM-
- •Current or recent use of aspirin (> 325 mg/day) or treatment with dipyramidole, ticlopidine, clopidogrel, and cilostazol.
- •Current unstable of full-dose oral or parenteral anticoagulants or thrombolytic agents for > 2 weeks prior to the first dose of LM-
- •Subjects who received major surgery or interventional treatment within 28 days prior to 1st dosing of LM-168 (excluding tumour biopsy, puncture, etc.).
- •Subjects who have severe cardiovascular disease.
- •Subjects who have uncontrolled or severe illness.
- •Subjects who have a history of immunodeficiency disease.
- •HIV infection, active infection including tuberculosis, HBV and HCV infection.
- •Subjects with a history of other malignancies within 5 years prior to the first administration of the study drug.
- •Child-bearing potential female who have positive results in pregnancy test or are lactating.
- •Subjects who have psychiatric illness or disorders that may preclude study compliance.
- •Subject who is judged as not eligible to participate in this study by the investigator.
研究组 & 干预措施
LM-168 Dose Escalation
Experimental
干预措施: LM-168 (Drug)
LM-168 Dose Expansion
Experimental
干预措施: LM-168 (Drug)
LM-168 combination dose escalation
Experimental
干预措施: LM-168 (Drug)
LM-168 combination dose escalation
Experimental
干预措施: Toripalimab (Drug)
LM-168 combination dose expansion
Experimental
干预措施: LM-168 (Drug)
LM-168 combination dose expansion
Experimental
干预措施: Toripalimab (Drug)
结局指标
主要结局
Temperature (Celsius)
时间窗: 78 weeks
Phase I
Blood Pressure in mmHg
时间窗: 78 weeks
Phase I
Incidence of adverse events (AEs)
时间窗: 78 weeks
Phase I
Incidence of dose-limitingtoxicity (DLT)
时间窗: 78 weeks
Phase I
Incidence of serious adverse event (SAE)
时间窗: 78 weeks
Phase I
Pulse in BPM(Beat per Minute)
时间窗: 78 weeks
Phase I
Weight in Kg
时间窗: 78 weeks
Phase I
Height in centimeter
时间窗: 78 weeks
Phase I
Blood Routine examination
时间窗: 78 weeks
Phase I
Urine Routine test
时间窗: 78 weeks
Phase I
Blood biochemistry test
时间窗: 78 weeks
Phase I
Coangulation function test
时间窗: 78 weeks
Phase I
Thyroid function test
时间窗: 78 weeks
Phase I
Echocardiography- LVEF(Left Ventricular Ejection Fraction) in percentage
时间窗: 78 weeks
Phase I
12-lead electrocardiogram (ECG) in HR
时间窗: 78 weeks
Phase I
12-lead electrocardiogram (ECG) in QT
时间窗: 78 weeks
Phase I
12-lead electrocardiogram (ECG) in RR
时间窗: 78 weeks
Phase I
12-lead electrocardiogram (ECG) in PR
时间窗: 78 weeks
Phase I
12-lead electrocardiogram (ECG) in QRS
时间窗: 78 weeks
Phase I
12-lead electrocardiogram (ECG) in QTcF
时间窗: 78 weeks
Phase I
ECOG(Eastern Cooperative Oncology Group) score
时间窗: 78 weeks
Phase I
Objective Response Rate (ORR)
时间窗: From 78th week to 130th week (52 weeks in total)
Phase II
次要结局
- Objective Response Rate (ORR)(78 weeks)
- Pharmacokinetic (PK) Parameter: Maximum Observed Concentration (Cmax)(130 weeks)
- PK Parameter:Time of Maximum Observed Concentration (Tmax)(130 weeks)
- PK Parameter: Area Under the Concentration-time Curve(AUC)(130 weeks)
- PK Parameter: Steady State Maximum Concentration(Cmax,ss) PK Parameter: Steady State Maximum Concentration(Cmax,ss)(130 weeks)
- progression-free survival (PFS) in Month(130 weeks)
- PK Parameter: Steady State Minimum Concentration(Cmin,ss)(130 weeks)
- PK Parameter: Elimination Half-life (t1/2)(130 weeks)
- PK Parameter: Systemic Clearance at Steady State (CLss)(130 weeks)
- Disease control rate (DCR) in percentage(130 weeks)
- PK Parameter: Accumulation Ratio (Rac)(130 weeks)
- PK Parameter: Volume of Distribution at Steady-State (Vss)(130 weeks)
- Duration of Response (DOR) in Month(130 weeks)
- Changes of target lesions from baseline in Millimeter(130 weeks)
- PK Parameter: Degree of Fluctuation (DF)(130 weeks)
- Immunogenicity testing(130 weeks)
- Temperature (Celsius)(From 78th week to 130th week (52 weeks in total))
- Pulse in BPM(Beat per Minute)(From 78th week to 130th week (52 weeks in total))
- Blood Pressure in mmHg(From 78th week to 130th week (52 weeks in total))
- Weight in Kg(From 78th week to 130th week (52 weeks in total))
- Height in centimeter(From 78th week to 130th week (52 weeks in total))
- Blood Routine examination(From 78th week to 130th week (52 weeks in total))
- Urine Routine test(From 78th week to 130th week (52 weeks in total))
- Blood biochemistry test(From 78th week to 130th week (52 weeks in total))
- Coangulation function test(From 78th week to 130th week (52 weeks in total))
- Thyroid function test(From 78th week to 130th week (52 weeks in total))
- Echocardiography- LVEF(Left Ventricular Ejection Fraction) in percentage(From 78th week to 130th week (52 weeks in total))
- ECOG(Eastern Cooperative Oncology Group) score(From 78th week to 130th week (52 weeks in total))
研究者
研究点 (6)
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