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TQB3824 blocks function of a specific protein called Cell Division Cycle 7 (CDC7) kinase in the human body, which plays important roles in the maintenance of DNA replication forks and DNA damage response pathways. This study will evaluate the safety, tolerability and pharmacokinetics of TQB3824.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TQB3824 tablets | Experimental | TQB3824 tablets orally administrated orally on Days 1-21 of each 21-day treatment cycle. Dose escalation of TQB3824 will be based on evaluation of clinical safety and tolerability and guided by accumulating PK data |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TQB3824 tablets | Drug | TQB3824 is a CDC7 inhibitor, which plays important roles in the maintenance of DNA replication forks and DNA damage response pathways. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose-limiting toxicity (DLT) | DLT describes side effects of a drug or other treatment that are serious enough to prevent an increase in dose or level of that treatment. | up to 18 months |
| Maximum Tolerated Dose (MTD) | The maximum Dose at which less than 33% subjects experiencing DLT | up to 18 months |
| Recommended Phase II Dose (RP2D) | RP2D will be based on evaluation of clinical safety and tolerability and guided by accumulating PK data | up to 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration-time curve (AUC) | Concentration Uncer Curve | up to 18 months |
| Maximum (peak) plasma drug concentration (Cmax) | Maximum plasma concentration of drug |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jihui Hao, Doctor | Contact | 022-23340123 | haojihui@tjmuch.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tianjin Medical University Cancer Institution & Hospital | Recruiting | Tianjin | Tianjin Municipality | 300181 | China |
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| up to 18 months |
| Time to reach maximum(peak )plasma concentration following drug administration (Tmax) | Time to Reach the Maximum Plasma Concentration | up to 18 months |
| Overall response rate (ORR) | The sum of percentage of participants with complete response rate and partial response rate | Baseline up to 12 months |
| Disease Control Rate (DCR ) | percentage of participants with complete response (CR), partial response (PR) plus stable disease (SD) | Baseline up to 12 months |
| Duration of Response (DOR) | the time from the date of first documentation of a CR or PR to the date of first documentation of tumor progression | Baseline up to 12 months |
| Progression-free survival (PFS) | Time from the first dose to the first documentation of PD or death from any cause, whichever occurs first | Baseline up to 12 months |
| Overall survival (OS) | the time from start of study treatment to date of death due to any cause | Baseline up to 12 months |