Trials / Unknown
UnknownNCT03664297
Tolerance and Pharmacokinetics of SHR1459 in Patients With Recurrent Replased/Refractory Mature B Cell Neoplasmstumor
Phase 1 Study to Evaluate the Tolerance and Pharmacokinetics of SHR1459 in Patients With Recurrentreplased/Refractory Mature B Cell Neoplasms Tumor
- Status
- Unknown
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 86 (actual)
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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);
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SHR1459 | SHR1459 will be administered continually till disease progression or unacceptable toxicity. |
Timeline
- Start date
- 2018-02-06
- Primary completion
- 2023-12-30
- Completion
- 2024-12-30
- First posted
- 2018-09-10
- Last updated
- 2022-11-14
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT03664297. Inclusion in this directory is not an endorsement.