This study is an open-label, multicenter Phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics and efficacy of HRS-3738 in patients with recurrent and refractory Non-Hodgkin's lymphoma and multiple myeloma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
198
HRS-3738 will be administrated per dose level in which the patients are assigned.
Henan cancer Hospital
Zhengzhou, Henan, China
NOT_YET_RECRUITINGSheng Jing Hospital of China Medical University
Shengyang, Liaoning, China
NOT_YET_RECRUITINGZhejiang University School of Medicine The First Affiliated Hospital
Hangzhou, Zhejiang, China
RECRUITINGMaximum tolerated dose (MTD)
Incidence and category of dose limiting toxicities (DLTs) during the first 28-day cycle of HRS-3738 treatment.
Time frame: From Day 1 to Day 28
RP2D
RP2D will be determined on the basis of evaluation on safety, PK, efficacy data in dose escalation and dose expansion stages.
Time frame: From Day 1 to Day 28
Safety endpoints: adverse events(AEs), serious adverse events(SAEs)
Assess safety and tolerability of HRS-3738 by way of adverse events (CTCAE v5.0).
Time frame: From Day 1 to 30 days after last dose.
Efficacy endpoints: Overall response rate (ORR)
Evaluated using Lugano 2014 criteria and IMWG criteria.
Time frame: From Day 1 to 30 days after last dose.
Efficacy endpoints: Best of response (BOR)
Evaluated using Lugano 2014 criteria and IMWG criteria
Time frame: From Day 1 to 30 days after last dose
Efficacy endpoints: time to response (TTR)
Evaluated using Lugano 2014 criteria and IMWG criteria.
Time frame: From Day 1 to 30 days after last dose.
Efficacy endpoints: Duration of response (DoR)
Evaluated using Lugano 2014 criteria and IMWG criteria
Time frame: From Day 1 to 30 days after last dose
Efficacy endpoints: Progression-free survival (PFS)
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Evaluated using Lugano 2014 criteria and IMWG criteria
Time frame: From Day 1 to 30 days after last dose
Efficacy endpoints: overall survival (OS).
Evaluated using Lugano 2014 criteria and IMWG criteria.
Time frame: From Day 1 to 30 days after last dose.
Cmax
Maximal plasma concentration
Time frame: From Day 1 to 30 days after last dose
Tmax
Time to Cmax
Time frame: From Day 1 to 30 days after last dose
AUC
Area under the plasma concentration-time curve
Time frame: From Day 1 to 30 days after last dose
t1/2
Terminal-phase elimination half-life
Time frame: From Day 1 to 30 days after last dose
Vz/F
Apparent volume of distribution during terminal phase after non-intravenous administration
Time frame: From Day 1 to 30 days after last dose
CL/F
Apparent total clearance of the drug from plasma after oral administration.
Time frame: From Day 1 to 30 days after last dose