Trial · NCT03664297
Tolerance and Pharmacokinetics of SHR1459 in Patients With Recurrent Replased/Refractory Mature B Cell Neoplasmstumor
NCT03664297, Phase 1, Unknown, Jiangsu HengRui Medicine Co., Ltd.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Tolerance and Pharmacokinetics of SHR1459 in Patients With Recurrent Replased/Refractory Mature B Cell Neoplasmstumor. Trials, record NCT03664297. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03664297
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Tolerance and Pharmacokinetics of SHR1459 in Patients With Recurrent Replased/Refractory Mature B Cell Neoplasmstumor
- NCT number
- NCT03664297
- Status
- Unknown
- Phases
- Phase 1
- Enrollment
- 86 participants, actual
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Conditions
- Mature B Cell Neoplasms
- Interventions
- SHR1459
- First posted
- 2018-09-10
- Last updated
- 2022-11-14
Source ClinicalTrials.gov
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence and severity of treatment-emergent adverse events (AEs) [Safety and Tolerability]) | through study completion, an average of about 6 months | The incidence and severity of treatment-emergent AEs will be collected and the safety and tolerability of SHR1459 will be assessed |
| Primary | Recommended phase 2 dose (RP2D) | 28 days since the date of first dose | 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 |
| Secondary | Objective response rate (ORR) | every 8 weeks through study completion, an average of about 6 months | Assess the response rate of subjects to the treatment of SHR1459 |
| Secondary | Duration of Response (DoR) | every 8 weeks through study completion, an average of about 6 months | Assess the duration of complete/partial response after the treatment of SHR1459 |
| Secondary | Progression-free survival (PFS) | every 8 weeks through study completion, an average of about 6 months | Assess the survival condition of the subjects after the treatment of SHR1459 |
| Secondary | Time to Response (TTR) | every 8 weeks through study completion, an average of about 6 months | Assess time to response of SHR 1459 after treatment |
| Secondary | Time to peak (Tmax) | Day 1 and Day 2 of the single dose | Pharmacokinetics profile of a single dose SHR1459 and its metabolite (plasma): Time to peak (Tmax) of plasma concentration |
| Secondary | Maximum plasma concentration (Cmax) | Day 1 and Day 2 of the single dose | Pharmacokinetics profile of a single dose SHR1459 and its metabolite (plasma): Maximum plasma concentration (Cmax) |
| Secondary | Halflife (T1/2) | Day 1 and Day 2 of the single dose | Pharmacokinetics profile of a single dose SHR1459 and its metabolite (plasma): Halflife (T1/2) |
| Secondary | Clearance/ bioavailability (CL/F) | Day 1 and Day 2 of the single dose | Pharmacokinetics profile of a single dose SHR1459 and its metabolite (plasma): Clearance/ bioavailability (CL/F) |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03664297
GET https://conductscience.org/api/trials/v1/NCT03664297/registered