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This project is an open, dose escalation and expansion phase I clinical study. The first phase is a dose escalation study, and the second phase is a dose expansion study based on the Maximum tolerated dose (MTD) / Recommended Phase II Dose (RP2D) obtained in the first phase. The purpose is to evaluate the tolerability and preliminary efficacy of TQB3702 tablets in hematological tumor subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TQB3702 tablets | Experimental | TQB3702 tablets were administered orally, 28 days as a treatment cycle until the progressive diseases or the investigator judges that it is not suitable for subject to continue to take this medicine. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TQB3702 tablets | Drug | TQB3702 tablets are selective BTK inhibitors. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum tolerated dose (MTD) | To evaluate the maximum tolerated dose of TQB3702 tablets in the treatment of relapsed/refractory hematologic tumors. | Baseline up to 104 weeks |
| Dose limited toxicity (DLT) | To evaluate the dose-limiting toxic dose of TQB3702 tablets in the treatment of relapsed/refractory hematologic tumors. | Baseline up to 104 weeks |
| Recommended Phase II Dose (RP2D) | To evaluate the phase II recommended dose of TQB3702 tablets in the treatment of relapsed/refractory hematological tumors. | Baseline up to 104 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Reach the Maximum Plasma Concentration (Tmax)-single dose | Time to Reach the Maximum Plasma Concentration after single dose | before administration, 0.25, 0.5, 0.75, 1, 2, 4, 6, 12, 24, 48, 72hours after administration. |
| Time to Reach the Maximum Plasma Concentration (Tmax)-multiple dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zengjun Li, Doctor | Contact | +86-13642138692 | zengjunli@163.com | |
| Fei Li, Doctor | Contact | +86-13970038386 | yx021021@sina.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Nanchang University | Nanchang | Jiangxi | 330006 | China |
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| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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Time to Reach the Maximum Plasma Concentration after multiple dose |
| before administration (-1~0h), 0.25, 0.5, 0.75, 1, 2, 4, 6, 12, 24 hours after administration at Day 8/15/28 of Cycle1, Day 28 of Cycle 6; when withdrawn from the group due to disease progression or at the end of study treatment. |
| Maximum plasma concentration (Cmax)-Single dose | Cmax is the maximum plasma concentration of TQB3702 after single dose | before administration, 0.25, 0.5, 0.75, 1, 2, 4, 6, 12, 24, 48, 72hours after administration. |
| Maximum plasma concentration (Cmax)-Multiple dose | Cmax is the maximum plasma concentration of TQB3702 after multiple dose | before administration (-1~0h), 0.25, 0.5, 0.75, 1, 2, 4, 6, 12, 24 hours after administration at Day 8/15/28 of Cycle1, Day 28 of Cycle 6; when withdrawn from the group due to disease progression or at the end of study treatment. |
| Elimination half-life (t1/2)-Single dose | t1/2 is time it takes for the blood concentration of TQB3702 or metabolite(s) to drop by half after single dose. | before administration, 0.25, 0.5, 0.75, 1, 2, 4, 6, 12, 24, 48, 72 hours after administration. |
| Elimination half-life (t1/2)-Multiple dose | t1/2 is time it takes for the blood concentration of TQB3702 or metabolite(s) to drop by half after multiple dose. | before administration (-1~0h), 0.25, 0.5, 0.75, 1, 2, 4, 6, 12, 24 hours after administration at Day 8/15/28 of Cycle1, Day 28 of Cycle 6; when withdrawn from the group due to disease progression or at the end of study treatment. |
| Area under the plasma concentration-time curve from time zero to time t (AUC0-t)-Single dose | To characterize the pharmacokinetics of TQB3702 by assessment of area under the plasma concentration time curve from the first dose to a certain time. | before administration, 0.25, 0.5, 0.75, 1, 2, 4, 6, 12, 24, 48, 72hours after administration. |
| Area under the plasma concentration-time curve from time zero to time t (AUC0-t)-Multiple dose | To characterize the pharmacokinetics of TQB3702 by assessment of area under the plasma concentration time curve from the first dose to a certain time. | before administration (-1~0h), 0.25, 0.5, 0.75, 1, 2, 4, 6, 12, 24 hours after administration at Day 8/15/28 of Cycle1, Day 28 of Cycle 6; when withdrawn from the group due to disease progression or at the end of study treatment. |
| Maximum (peak) steady-state plasma drug concentration during a dosage interval (Cmax,ss)-Single dose | Maximum (peak) steady-state plasma drug concentration during a dosage interval (Cmax,ss) after Single dose | before administration, 0.25, 0.5, 0.75, 1, 2, 4, 6, 12, 24, 48, 72hours after administration. |
| Maximum (peak) steady-state plasma drug concentration during a dosage interval (Cmax,ss)-Multiple dose | Maximum (peak) steady-state plasma drug concentration during a dosage interval (Cmax,ss) after Multiple dose | before administration (-1~0h), 0.25, 0.5, 0.75, 1, 2, 4, 6, 12, 24 hours after administration at Day 8/15/28 of Cycle1, Day 28 of Cycle 6; when withdrawn from the group due to disease progression or at the end of study treatment. |
| steady state area under the concentration-time curve over a dosing interval (AUCtau, ss)-single dose | steady state area under the concentration-time curve over a dosing interval (AUCtau, ss) after single dose | before administration, 0.25, 0.5, 0.75, 1, 2, 4, 6, 12, 24, 48, 72hours after administration. |
| steady state area under the concentration-time curve over a dosing interval (AUCtau, ss)-multiple dose | steady state area under the concentration-time curve over a dosing interval (AUCtau, ss) after multiple dose | before administration (-1~0h), 0.25, 0.5, 0.75, 1, 2, 4, 6, 12, 24 hours after administration at Day 8/15/28 of Cycle1, Day 28 of Cycle 6; when withdrawn from the group due to disease progression or at the end of study treatment. |
| Minimum steady-state plasma drug concentration during a dosage interval (Css-min)-Single dose | Minimum steady-state plasma drug concentration during a dosage interval (Cmin-ss) after Single dose | before administration, 0.25, 0.5, 0.75, 1, 2, 4, 6, 12, 24, 48, 72hours after administration. |
| Minimum steady-state plasma drug concentration during a dosage interval (Css-min)-multiple dose | Minimum steady-state plasma drug concentration during a dosage interval (Cmin-ss) after multiple dose | before administration (-1~0h), 0.25, 0.5, 0.75, 1, 2, 4, 6, 12, 24 hours after administration at Day 8/15/28 of Cycle1, Day 28 of Cycle 6; when withdrawn from the group due to disease progression or at the end of study treatment. |
| Objective Response Rate (ORR) | The proportion of patients with tumor size reduction of a predefined amount and for a minimum time period | Baseline up to 104 weeks |
| Complete Remission Rate (CRR) | The proportion of tumors that have a complete response after treatment | Baseline up to 104 weeks |
| Disease Control Rate (DCR) | The percentage of patients with advanced or metastatic cancer who have achieved complete response, partial response and stable disease to a cancer treatment in clinical trials. | Baseline up to 104 weeks |
| Duration of Response (DOR) | The time from the date of first documentation of a CR or PR or PD to the date of first documentation of tumor progression. | Baseline up to 104 weeks |
| Progression Free Survival (PFS) | The time from the first dose to the first documentation of progressive disease (PD) or death from any cause, whichever occurs first | Baseline up to 104 weeks |
| Overall Survival (OS) | the time from start of study treatment to date of death due to any cause | Baseline up to 104 weeks |
| Adverse events (AE) | The occurrence of all adverse events (AE) | Baseline up to 104 weeks |
| Serious adverse events (SAE) | The occurrence of all serious adverse events (SAE) | Baseline up to 104 weeks |
| Bruton's tyrosine kinase (BTK) occupancy | The BTK occupancy in peripheral blood mononuclear cell (PMBC) | Baseline up to 104 weeks |
| The Cancer Hospital Affiliated to Shandong First Medical University | Jinan | Shandong | 250117 | China |
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