NCT05615974招募中1 期
A Phase I/II, Open-label, Dose Escalation, and Dose Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Preliminary Efficacy of LM-101 Injection as a Single Agent or Combination Therapy in Patients With Advanced Malignant Tumors
适应症
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
- 139
- 试验地点
- 5
- 主要终点
- Incidence of dose-limitingtoxicity (DLT)
研究概览
简要总结
This study is to assess the safety and tolerability, obtain Maximum Tolerated Dose (MTD) and/or the recommended phase 2 dose (RP2D) of LM-101 as a single agent or in combination in patients with advanced malignant tumors
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Subjects who are willing to participate in the study and sign the informed consent form (ICF) prior to any procedure.
- •Aged ≥18 years old, male or female.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-
- •Life expectancy ≥ 3 months.
- •Subjects must have histological or cytological confirmation of recurrent or refractory advanced solid tumors, and have progressed on standard therapy.
- •At least one evaluable lesion.
- •Subjects in the combination therapy group must have Archived Samples or fresh tumor tissue specimens are required for testing.
- •Subjects must show appropriate organ and marrow function in laboratory examinations within 7 days prior to the first dose:
- •Women of childbearing potential (WOCBP) must agree to use highly effective methods of contraception prior to study entry, during the study and for 6 months after the last dose of study drug.
- •Subjects who can communicate well with investigators and understand and adhere to the requirements of this study.
排除标准
- •Subject has received prior investigational therapy directed at the same target therapy.
- •Subjects has participated in any other interventional clinical trial within 21 days prior to the first dosing of LM-
- •Subjects with anti-tumor treatment within 21 days prior to the first dosing of LM-101, including radiotherapy, chemotherapy, endocrine therapy, and immunotherapy, etc.
- •Any adverse event from prior anti-tumor therapy has not yet recovered to ≤ grade 1 of CTCAE v5.
- •Poorly controlled tumor-related pain.
- •Subjects with symptomatic/active central nervous system (CNS) metastases.
- •Subjects who have uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures.
- •Subjects with known hypersensitivity to antibody therapy.
- •Subjects who take systemic corticosteroids (> 10 mg daily prednisone equivalents) or other systemic immunosuppressive medicationswithin 2 weeks prior to the first dosing of LM-
- •Subjects with the known history of autoimmune disease with the exception of subjects with a history of autoimmune-related hypothyroidism on a stable dose of thyroid-replacement hormone.
- •Subject who has interstitial lung disease or a history of pneumonitis that required oral or intravenous glucocorticoids to assist with management.
- •Use of any live attenuated vaccines within 28 days prior to the first dosing of LM-
- •Subjects who are using therapeutic doses of anticoagulants such as heparin or vitamin K antagonists.
- •Subjects who received major surgery or interventional treatment within 28 days prior to the first dosing of LM-101 (excluding tumor biopsy, puncture, etc.).
- •Subjects who have history of severe cardiovascular disease.
- •Subjects who have uncontrolled or severe illness.
- •Subjects who have a history of immunodeficiency disease.
- •HIV infection, active tuberculosis or active HBV and HCV infection.
- •Subjects who have Known history of active tuberculosis.
- •Subjects who have other active invasive cancers, other than the one treated in this trial, within 5 years prior to screening.
- •Child-bearing potential female who have positive results in pregnancy test or are lactating.
- •Subject who have a known psychiatric diseases or disorders that may affect compliance with the trial.
- •Subject who is judged as not eligible to participate in this study by the investigator.
研究组 & 干预措施
LM101 combination therapy exploratory
Experimental
干预措施: Toripalimab (Drug)
LM101 combination therapy exploratory
Experimental
干预措施: Rituximab (Drug)
LM101 combination expansion
Experimental
干预措施: LM101 (Drug)
LM101 combination expansion
Experimental
干预措施: Toripalimab (Drug)
LM101 combination expansion
Experimental
干预措施: Rituximab (Drug)
LM101 Dose Escalation
Experimental
干预措施: LM101 (Drug)
LM101 combination therapy exploratory
Experimental
干预措施: LM101 (Drug)
结局指标
主要结局
Incidence of dose-limitingtoxicity (DLT)
时间窗: 48 weeks
Phase 1
Incidence of adverse events (AEs)
时间窗: 48 weeks
Phase 1
Incidence of serious adverse event (SAE)
时间窗: 48 weeks
Phase 1
Temperature in ℃
时间窗: 48 weeks
Phase 1
Pulse in BPM(Beat per Minute)
时间窗: 48 weeks
Phase 1
Blood Pressure in mmHg
时间窗: 48 weeks
Phase 1
Weight in Kg
时间窗: 48 weeks
Phase 1
Height in centimeter
时间窗: 48 weeks
Phase 1
Laboratory tests-Blood Routine examination
时间窗: 48 weeks
Phase 1
Laboratory tests-Urine Routine test
时间窗: 48 weeks
Phase 1
Laboratory tests-Blood biochemistry
时间窗: 48 weeks
Phase 1
Laboratory tests- Coangulation function
时间窗: 48 weeks
Phase 1
Echocardiography- LVEF(Left Ventricular Ejection Fraction) in percentage
时间窗: 48 weeks
Phase 1
12-lead electrocardiogram (ECG) in QTcF.
时间窗: 48 weeks
Phase 1
12-lead electrocardiogram (ECG) in QT.
时间窗: 48 weeks
Phase 1
12-lead electrocardiogram (ECG) in QRS.
时间窗: 48 weeks
Phase 1
12-lead electrocardiogram (ECG) in HR.
时间窗: 48 weeks
Phase 1
12-lead electrocardiogram (ECG) in RR.
时间窗: 48 weeks
Phase 1
12-lead electrocardiogram (ECG) in PR.
时间窗: 48 weeks
Phase 1
ECOG(Eastern Cooperative Oncology Group) score
时间窗: 48 weeks
Phase 1
Overall Response Rate (ORR)
时间窗: 64 weeks
Phase 2
次要结局
- Laboratory tests-Blood biochemistry(64 weeks)
- Laboratory tests- Coangulation function(64 weeks)
- 12-lead electrocardiogram (ECG) in RR, PR, QRS, QT, QTcF etc.(64 weeks)
- ECOG(Eastern Cooperative Oncology Group) score(64 weeks)
- Pharmacokinetic (PK) Parameter: Maximum Observed Concentration (Cmax)(112 weeks)
- PK Parameter:Time of Maximum Observed Concentration (Tmax)(112 weeks)
- PK Parameter: Area Under the Concentration-time Curve(AUC)(112 weeks)
- PK Parameter: Steady State Maximum Concentration(Cmax,ss)(112 weeks)
- PK Parameter: Steady State Minimum Concentration(Cmin,ss)(112 weeks)
- PK Parameter: Systemic Clearance at Steady State (CLss)(112 weeks)
- PK Parameter: Accumulation Ratio (Rac)(48 weeks)
- PK Parameter: Elimination Half-life (t1/2)(112 weeks)
- PK Parameter: Volume of Distribution at Steady-State (Vss)(112 weeks)
- PK Parameter: Degree of Fluctuation (DF)(112 weeks)
- Immunogenicity of LM-101(112 weeks)
- Receptor Occupancy of LM-101(48 weeks)
- Biomarker correlation (CD8/CD47/CD68/CD163/PD-L1)(112 weeks)
- Duration of Response (DOR) in Month(64 weeks)
- Disease control rate (DCR) in percentage(64 weeks)
- progression-free survival (PFS) in Month(64 weeks)
- Overall survival (OS) in Month(64 weeks)
- Changes of target lesions from baseline in Millimeter.(64 weeks)
- Safety: AE/SAE (Number of participants with treatment-related adverse events as assessed by CTCAE v5.0)(64 weeks)
- Temperature in ℃(64 weeks)
- Pulse in BPM(Beat per Minute)(64 weeks)
- Blood Pressure in mmHg(64 weeks)
- Weight in Kg(64 weeks)
- Height in centimeter(64 weeks)
- Laboratory tests-Blood Routine examination(64 weeks)
- Laboratory tests-Urine Routine test(64 weeks)
研究者
研究点 (5)
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