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
74
HRS-3738 will be administrated per dose level in which the patients are assigned.
Henan cancer Hospital
Zhengzhou, Henan, China
Sheng Jing Hospital of China Medical University
Shengyang, Liaoning, China
Zhejiang University School of Medicine The First Affiliated Hospital
Hangzhou, Zhejiang, China
Maximum 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