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This study is a multi-center, open, dose-increasing and dose-expanding phase I clinical study, aiming at evaluating the safety, tolerability, pharmacokinetic characteristics and preliminary anti-tumor activity of LIT-00814 tablets with different doses in China, and preliminarily evaluating the relationship between biomarkers and anti-tumor activity of LIT-00814 tablets.
This study includes two parts: Ia phase (i.e. dose escalation) and Ib phase (i.e. dose expansion).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LIT-00814 20mg | Experimental | Take a fixed dose of LIT-00814 tablets orally once a day in the morning and evening, and take them orally continuously. |
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| LIT-00814 50mg | Experimental | Take a fixed dose of LIT-00814 tablets orally once a day in the morning and evening, and take them orally continuously. |
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| LIT-00814 100mg | Experimental | Take a fixed dose of LIT-00814 tablets orally once a day in the morning and evening, and take them orally continuously. |
|
| LIT-00814 150mg | Experimental | Take a fixed dose of LIT-00814 tablets orally once a day in the morning and evening, and take them orally continuously. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LIT-00814 | Drug | LIT-00814 is an oral tablet. |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events | Up to 28 days post last drug administration | |
| Determination of the MTD and RP2D of LIT-00814 monotherapy | Defined as the highest dose level at which no more than 1 of 6 subjects experience a DLT during the DLT assessment window(24days) | 24 days after the first dose |
| Measure | Description | Time Frame |
|---|---|---|
| Objective remission rate (ORR) | according to the criterion of RECIST1.1, the proportion of subjects with complete remission (CR) and partial remission (PR) during the study period. | Until documented the disease progresses or informed consent is withdrawn |
| Disease control rate (DCR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jing Huang, Professor | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Hospital, Chinese Academy of Medical Sciences | Beijing | Beijing Municipality | 100000 | China |
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According to the criterion of RECIST1.1, the proportion of subjects with complete remission (CR), partial remission (PR) and stable disease (SD) during the study period. |
| Until documented the disease progresses or informed consent is withdrawn |
| Disease progression-free survival (PFS) | It is defined as the time between the first administration date of the study drug and the disease progression or death, whichever occurs first. | Until documented the disease progresses or informed consent is withdrawn |
| Treatment onset time (TTR) | It is defined as the time between the first administration date of the study drug and the first determination of complete remission (CR) and partial remission (PR). | Until documented the disease progresses or informed consent is withdrawn |
| Overall survival (OS) | The time from the first administration date of the study drug to the death (for any reason) of the subject. | date of death from any cause or withdrawal of informed consent |
| Pharmacokinetic parameters:Maximum observed concentration(Cmax) | Maximum concentration of LIT-00814 in blood after single dose and continuous multiple doses | C0D1-D3 0-72h(single dose),C1D1 0h、C1D8 0h、C2D1 0-8h(21days/cycle) |
| Pharmacokinetic parameters:Area under the concentration-time curve (AUC) | The concentration of LIT-00814 in blood after single dose and continuous multiple doses | C0D1-D3 0-72h(single dose),C1D1 0h、C1D8 0h、C2D1 0-8h(21days/cycle) |
| Pharmacokinetic parameters:Half-life (t1/2) | The concentration of LIT-00814 in blood after single dose and continuous multiple doses | C0D1-D3 0-72h(single dose),C1D1 0h、C1D8 0h、C2D1 0-8h(21days/cycle) |