Mature B Cell NeoplasmsPhase 1NCT03664297
Tolerance and Pharmacokinetics of SHR1459 in Patients With Recurrent Replased/Refractory Mature B Cell Neoplasmstumor
A Phase 1 study testing SHR1459 in people with Mature B Cell Neoplasms, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Mature B Cell Neoplasms
- What is being tested?
- SHR1459
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteChina
- Study dates
- 6 Feb 2018to 30 Dec 2024
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ECOG Performance Status [PS] score must be 0 or 1;
- Life expectancy ≥ 12 weeks;
- Mature B cell eoplasmss with histological or cytological diagnosis, including diffuse large B cell lymphoma (DLBCL), follicular lymphoma (FL) , chronic lymphocytic leukemia/Small lymphocytic lymphoma (CLL/SLL), Mantle cell lymphoma (MCL), Marginal zone lymphoma (MZL) and waldenstrom macroglobulinemia (WM);
- The function of bone marrow is basically normal;
- Renal function is basically normal;
- Hepatic function is basically normal.
Who cannot join
- Had received treatment with the compound of the same mechanism (BTK inhibitor);
- With infiltration of lymphoma central nervous system;
- Received autologous stem cell transplantation within 60 days before signing the informed consent, received allogeneic stem cell transplantation in 90 days (after allogeneic stem cell transplantation, if graft-versus-host disease appeared, it must be ≤ level 1, and if there was no prohibited medication, the screening could be performed);
Trial locations and contacts
1 site in 1 country.
China1 site
Blood disease hospital of Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, 300000
About this study
Official title: Phase 1 Study to Evaluate the Tolerance and Pharmacokinetics of SHR1459 in Patients With Recurrentreplased/Refractory Mature B Cell Neoplasms 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.
Read the 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
- Mature B Cell Neoplasms
- Being tested
- SHR1459
- Keywords
- replased/refractory mature B cell neoplasms, BTK inhibitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR1459Drug
Also called No other intervention
SHR1459 will be administered continually till disease progression or unacceptable toxicity.
| Study group | Role | What they receive |
|---|---|---|
| SHR1459 | Experimental | Oral administration, once a day, 28 days for a cycle, until the disease progression or the intolerable toxicity occurs. Receives: Drug: SHR1459 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 28 days since the date of first dose
Secondary outcomes (17)
Objective response rate (ORR)
Assess the response rate of subjects to the treatment of SHR1459
Measured: every 8 weeks through study completion, an average of about 6 months
Duration of Response (DoR)
Assess the duration of complete/partial response after the treatment of SHR1459
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Day 1 of cycle 1 to day 1 of cycle 4 (28 days/cycle)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2018
- Study start6 Feb 2018
- Primary completion30 Dec 2023 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mature B Cell NeoplasmsStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lugui Qiu, Principal investigator, Blood Institute of the Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03664297
- Sponsor's protocol ID
- SHR1459-I-101
- Status last verified
- Nov 2022
- First submitted
- 6 Sep 2018
- Last updated
- 14 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No