HRS-3738
DrugHRS-3738 will be administrated per dose level in which the patients are assigned.
NCT Number: NCT05363800
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.
This study is active but is not currently recruiting participants.
Notify Me18 year and older
All sexes
Interventional
Phase 1
Henan cancer Hospital, Zhengzhou, Henan, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
HRS-3738 will be administrated per dose level in which the patients are assigned.
Time frame: From Day 1 to Day 28
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 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 30 days after last dose.
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.
Evaluated using Lugano 2014 criteria and IMWG criteria.
Time frame: From Day 1 to 30 days after last dose
Evaluated using Lugano 2014 criteria and IMWG criteria
Time frame: From Day 1 to 30 days after last dose.
Evaluated using Lugano 2014 criteria and IMWG criteria.
Time frame: From Day 1 to 30 days after last dose
Evaluated using Lugano 2014 criteria and IMWG criteria
Time frame: From Day 1 to 30 days after last dose
Evaluated using Lugano 2014 criteria and IMWG criteria
Time frame: From Day 1 to 30 days after last dose.
Evaluated using Lugano 2014 criteria and IMWG criteria.
Time frame: From Day 1 to 30 days after last dose
Maximal plasma concentration
Time frame: From Day 1 to 30 days after last dose
Time to Cmax
Time frame: From Day 1 to 30 days after last dose
Area under the plasma concentration-time curve
Time frame: From Day 1 to 30 days after last dose
Terminal-phase elimination half-life
Time frame: From Day 1 to 30 days after last dose
Apparent volume of distribution during terminal phase after non-intravenous administration
Time frame: From Day 1 to 30 days after last dose
Apparent total clearance of the drug from plasma after oral administration.
Jiangsu HengRui Medicine Co., Ltd.
Industry
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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