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SHR1459 is a selective small molecule BTK inhibitor developed by Jiangsu Hengrui medicine Limited, by inhibiting the phosphorylation of BTK and down regulation of BCR signal transduction pathway, And then selectively inhibit the proliferation and migration of B cell tumor.
SHR1459 is a selective small molecule BTK inhibitor developed by Jiangsu Hengrui medicine Limited, by inhibiting the phosphorylation of BTK and down regulation of BCR signal transduction pathway, And then selectively inhibit the proliferation and migration of B cell tumor. The objective of this phase 1 study is to evaluate the safety and tolerance of SHR1459 in patients with replaced/refractory mature B cell neoplasms, in order to determine the maximum tolerated dose (MTD) and recommended dose for phase 2 clinical study (RP2D);
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR1459 | Experimental | Oral administration, once a day, 28 days for a cycle, until the disease progression or the intolerable toxicity occurs. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR1459 | Drug | SHR1459 will be administered continually till disease progression or unacceptable toxicity. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of treatment-emergent adverse events (AEs) [Safety and Tolerability]) | The incidence and severity of treatment-emergent AEs will be collected and the safety and tolerability of SHR1459 will be assessed | through study completion, an average of about 6 months |
| Recommended phase 2 dose (RP2D) | Recommended phase 2 dose (RP2D) and/or maximum tolerated dose (MTD) will be established according to the incidence of dose-limiting toxicities (DLTs) of escalated doses of SHR1459 | 28 days since the date of first dose |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) | Assess the response rate of subjects to the treatment of SHR1459 | every 8 weeks through study completion, an average of about 6 months |
| Duration of Response (DoR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lugui Qiu | Blood Institute of the Chinese Academy of Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Blood disease hospital of Chinese Academy of Medical Sciences | Tianjin | Tianjin Municipality | 300000 | China |
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Assess the duration of complete/partial response after the treatment of SHR1459
| every 8 weeks through study completion, an average of about 6 months |
| Progression-free survival (PFS) | Assess the survival condition of the subjects after the treatment of SHR1459 | every 8 weeks through study completion, an average of about 6 months |
| Time to Response (TTR) | Assess time to response of SHR 1459 after treatment | every 8 weeks through study completion, an average of about 6 months |
| Time to peak (Tmax) | Pharmacokinetics profile of a single dose SHR1459 and its metabolite (plasma): Time to peak (Tmax) of plasma concentration | Day 1 and Day 2 of the single dose |
| Maximum plasma concentration (Cmax) | Pharmacokinetics profile of a single dose SHR1459 and its metabolite (plasma): Maximum plasma concentration (Cmax) | Day 1 and Day 2 of the single dose |
| Halflife (T1/2) | Pharmacokinetics profile of a single dose SHR1459 and its metabolite (plasma): Halflife (T1/2) | Day 1 and Day 2 of the single dose |
| Clearance/ bioavailability (CL/F) | Pharmacokinetics profile of a single dose SHR1459 and its metabolite (plasma): Clearance/ bioavailability (CL/F) | Day 1 and Day 2 of the single dose |
| apparent volume of distribution/bioavailability (Vd/F) | Pharmacokinetics profile of a single dose SHR1459 and its metabolite (plasma): apparent volume of distribution/bioavailability (Vd/F) | Day 1 and Day 2 of the single dose |
| Area under curve (AUC) | Pharmacokinetics profile of a single dose SHR1459 and its metabolite (plasma): Area under curve (AUC) | Day 1 and Day 2 of the single dose |
| Area under curve, steady state (AUCss) | Pharmacokinetics profile of a single dose SHR1459 and its metabolite (plasma): Area under curve, steady state (AUCss) | Day 1 of cycle 1 to day 1 of cycle 4 (28 days/cycle) |
| Maximum plasma concentration, steady state (Cmax,ss) | Pharmacokinetics profile of a single dose SHR1459 and its metabolite (plasma): Maximum plasma concentration, steady state (Cmax,ss) | Day 1 of cycle 1 to day 1 of cycle 4 (28 days/cycle) |
| Time to peak, steady state (Tmax,ss) | Pharmacokinetics profile of a single dose SHR1459 and its metabolite (plasma): Time to peak, steady state (Tmax,ss) | Day 1 of cycle 1 to day 1 of cycle 4 (28 days/cycle) |
| Halflife (T1/2) | Pharmacokinetics profile of a single dose SHR1459 and its metabolite (plasma): Halflife (T1/2) | Day 1 of cycle 1 to day 1 of cycle 4 (28 days/cycle) |
| Apparent volume of distribution, steady state/bioavailability (Vss/F) | Pharmacokinetics profile of a single dose SHR1459 and its metabolite (plasma): Apparent volume of distribution, steady state/bioavailability (Vss/F) | Day 1 of cycle 1 to day 1 of cycle 4 (28 days/cycle) |
| Clearance/ bioavailability (CL/F) | Pharmacokinetics profile of a single dose SHR1459 and its metabolite (plasma): Clearance/ bioavailability (CL/F) | Day 1 of cycle 1 to day 1 of cycle 4 (28 days/cycle) |
| Accumulation index (Rac) | Pharmacokinetics profile of a single dose SHR1459 and its metabolite (plasma): Accumulation index (Rac) | Day 1 of cycle 1 to day 1 of cycle 4 (28 days/cycle) |