The dose escalation scheme using the the accelerated titration design for dose 1 and the i3+3 design for the remaining doses.

first dose: 2.5mg QD, n=1;

The dose escalation scheme using the the accelerated titration design for dose 1 and the i3+3 design for the remaining doses.

second dose: 5mg QD, n=3;

The dose escalation scheme using the the accelerated titration design for dose 1 and the i3+3 design for the remaining doses.

third dose: 10mg QD, n=3;

The dose escalation scheme using the the accelerated titration design for dose 1 and the i3+3 design for the remaining doses.

fourth dose: 20mg, n=3;

The dose escalation scheme using the the accelerated titration design for dose 1 and the i3+3 design for the remaining doses.

fifth dose: 30mg, n=3;

The dose escalation scheme using the the accelerated titration design for dose 1 and the i3+3 design for the remaining doses.

sixth dose: 40mg, n=9;

The dose escalation scheme using the the accelerated titration design for dose 1 and the i3+3 design for the remaining doses.

seventh dose: 60mg, n=15;

The subjects in each dose level will be administered single oral dose of LM-061 tablet on C0D1, and washout for 5 days. After that, the subjects will be administered multiple oral doses once daily (QD) in continuous 28 days (4 weeks) per treatment cycle, until meet the treatment termination criteria, including disease progression or unaccepted toxicity, etc. After obtaining MTD/RP2D, the Safety Review Committee (SRC) may combine the data of safety, PK, and preliminary efficacy to explore other dosing schedules (such as 3 weeks on and 1 week off).

LM-061

This is a phase I/II, open-label, dose escalation and dose extension study to evaluate the safety, tolerability, PK, and preliminary efficacy of LM-061 in subjects with advanced tumors.

This is a phase I/II, open-label, dose escalation and dose extension study to evaluate the safety, tolerability, PK, and preliminary efficacy of LM-061 in subjects with advanced tumors.

The study schedule includes screening visit (28 days prior to accept the investigational medicinal product (IMP)), treatment visit (accept IMP for the first time to the end of treatment (EOT)/early withdrawal), and follow-up visit (28 days after the EOT/early withdrawal).

Arm1: LM-061 2.5mg P.O QD Arm2: LM-061 5mg, P.O QD Arm3: LM-061 10mg, P.O QD Arm4: LM-061 20mg, P.O QD Arm5: LM-061 30mg, P.O QD Arm6: LM-061 40mg, P.O QD Arm7: LM-061 60mg, P.O QD

A Clinical Study Preliminary Efficacy of LM-061 Tablet in Subjects With Advanced Tumours

A Phase I/II, First-in-Human, Open-Label, Dose-Escalation and Dose-Extension Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of LM-061 Tablet in Subjects With Advanced Tumours

The safety profile of LM061 will be assessed by monitoring the adverse events (AE) per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0

DLT is defined as a toxicity (adverse event at least possibly related to LM061) occurring during the DLT observation period (the initial 21 days)

MTD is defined as the dose for which the probability of DLT does not exceed the upper bound of the EI, 0.35, and is closest to the target toxicity probability p_T=0.3 during the DLT assessment period (from LM-061 single dose to the first treatment cycle of the multiple dose).

The i3+3 design does not select a dose as the MTD unless at least 3 subjects have completed the safety assessment.

Change in vital signs-ear temperature will be measured after the subject has been fully rested.

Change in vital signs-pulse rate will be measured after the subject has been fully rested.

Change in vital signs-blood pressure will be measured after the subject has been fully rested.

RR interval of 12-lead ECG will be performed in the supine position after the patients are fully rested at each timepoint for once. RR is the standard heart rate which calculated by 60 divided by heart rate.

QT interval of 12-lead ECG will be performed in the supine position after the patients are fully rested at each timepoint for once.

QRS duration of 12-lead ECG will be performed in the supine position after the patients are fully rested at each timepoint for once.

Number of participants with incidence of abnormal clinical lab test results like hematology will be assessed.

Number of participants with incidence of abnormal clinical lab test results like Biochemistry will be assessed.

Number of participants with incidence of abnormal clinical lab test results like Urinalysis will be assessed.

Number of participants with incidence of abnormal clinical lab test results like Coagulation test will be assessed.

To determine the pharmacokinetics (PK) profile of LM061 Single dose: pre-dose (within 30 minutes before administration), and 1 h, 3 h, 6 h, 8 h, 10 h, 12 h, 24 h, 36 h, 48 h, 72 h, 96 h after administration on C0D1; Multiple dose: pre-dose (within 30 minutes before administration) on C1D1, C1D8, and C1D15; pre-dose (within 30 minutes before administration), and 1 h, 3 h, 6 h, 8 h, 10 h, 12 h, 24 h after administration on C1D22;

The timepoints of PK sample may be adjusted base on the human PK data. The blood samples for PK analysis will be collected as much as possible if the subjects end of treatment/early withdraw.

To determine the pharmacokinetics (PK) profile of LM061 For AML, the efficacy will be evaluated by using the European LeukemiaNet (ELN) 2017 criteria. The complete blood count and bone marrow will be evaluated at screening visit and every 4 weeks ± 1 week (relative to C1D1) after the start of multiple administrations until the progressive disease judged by investigator or initiate new anti-tumour therapy or subject withdraw. The assessment results are divided into complete remission (CR), CR without minimal residual disease (CRMRD-)，CR with incomplete hematologic recovery (CRi), morphologic leukemia-free state (MFLS), partial remission (PR), stable disease (SD), progressive disease (PD).

To determine the pharmacokinetics (PK) profile of LM061

To assess the preliminary antitumor activity of LM102,The ORR, using RECIST 1.1 criteria, was defined as the percentage of participants in the analysis population who had a confirmed Complete Response (CR; disappearance of all target lesions) or Partial Response (PR; at least a 30% decrease in the sum of diameters of target lesions) at any time during the study, based on Investigator assessment.

To assess the preliminary antitumor activity of LM061

Spots Global Cancer Trial Database for A Clinical Study Preliminary Efficacy of LM-061 Tablet in Subjects With Advanced Tumours

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