Back to resultsPhase I Study of HRS-3738 in Recurrent and Refractory Non-Hodgkin's Lymphoma and Multiple Myeloma
Primary Purpose
Recurrent and Refractory Non-Hodgkin's Lymphoma and Multiple Myeloma
Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
HRS-3738
Sponsored by
About this trial
This is an interventional treatment trial for Recurrent and Refractory Non-Hodgkin's Lymphoma and Multiple Myeloma
Eligibility Criteria
Inclusion Criteria:
- Active multiple myeloma in accordance with IMWG criteria，or histopathologically and immunohistochemically confirmed non-Hodgkin's lymphoma in accordance with the 2016 WHO Classification of lymphoid neoplasias.
- Recurred or did not alleviate after the previous treatment.
- Have at least one measurable lesion.
- With a life expectancy of ≥3 months.
- Male or female ≥ 18 years old.
- ECOG performance status of 0-1.
- Subjects must voluntarily agree to participate in the trial and sign a written informed consent form.
Exclusion Criteria:
- Amyloidosis, plasma cell leukemia.
- Corrected serum calcium>3.4mmol/L(13.5mg/dl).
- Presence of metastasis to central nervous system.
- Treatment of other investigational products.
- Major surgical therapy within 28 days prior to the date of signature of informed consent form, or expected major surgery during the study.
- Known history of hypersensitivity to any components of HRS-3738.
- Other factors that may affect the study results or lead to forced termination of the study early as judged by investigators.
Sites / Locations
- Henan cancer Hospital
- Sheng Jing Hospital of China Medical University
- Zhejiang University School of Medicine The First Affiliated HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
HRS-3738
Arm Description
In dose Escalation: HRS-3738 will be taken in oral. Seven dose levels are preset. In dose Expansion: 2 to 3 dose cohorts will be selected for dose expansion stage. In indication Expansion: Indications will be selected to evaluate preliminary efficacy.
Outcomes
Primary Outcome Measures
Maximum tolerated dose (MTD)
Incidence and category of dose limiting toxicities (DLTs) during the first 28-day cycle of HRS-3738 treatment.
RP2D
RP2D will be determined on the basis of evaluation on safety, PK, efficacy data in dose escalation and dose expansion stages.
Secondary Outcome Measures
Safety endpoints: adverse events(AEs), serious adverse events（SAEs）
Assess safety and tolerability of HRS-3738 by way of adverse events (CTCAE v5.0).
Efficacy endpoints: Overall response rate (ORR)
Evaluated using Lugano 2014 criteria and IMWG criteria.
Efficacy endpoints: Best of response (BOR)
Evaluated using Lugano 2014 criteria and IMWG criteria
Efficacy endpoints: time to response (TTR)
Evaluated using Lugano 2014 criteria and IMWG criteria.
Efficacy endpoints: Duration of response (DoR)
Evaluated using Lugano 2014 criteria and IMWG criteria
Efficacy endpoints: Progression-free survival (PFS)
Evaluated using Lugano 2014 criteria and IMWG criteria
Efficacy endpoints: overall survival (OS).
Evaluated using Lugano 2014 criteria and IMWG criteria.
Cmax
Maximal plasma concentration
Tmax
Time to Cmax
AUC
Area under the plasma concentration-time curve
t1/2
Terminal-phase elimination half-life
Vz/F
Apparent volume of distribution during terminal phase after non-intravenous administration
CL/F
Apparent total clearance of the drug from plasma after oral administration.
Full Information
NCT ID
NCT05363800
First Posted
April 25, 2022
Last Updated
July 27, 2022
Sponsor
Jiangsu HengRui Medicine Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05363800
Brief Title
Phase I Study of HRS-3738 in Recurrent and Refractory Non-Hodgkin's Lymphoma and Multiple Myeloma
Official Title
Phase I Study of HRS-3738 in Recurrent and Refractory Non-Hodgkin's Lymphoma and Multiple Myeloma
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 17, 2022 (Actual)
Primary Completion Date
October 30, 2024 (Anticipated)
Study Completion Date
December 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu HengRui Medicine Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent and Refractory Non-Hodgkin's Lymphoma and Multiple Myeloma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Model Description
Single arm study of HRS-3738
Masking
None (Open Label)
Allocation
N/A
Enrollment
198 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
HRS-3738
Arm Type
Experimental
Arm Description
In dose Escalation:
HRS-3738 will be taken in oral. Seven dose levels are preset.
In dose Expansion:
2 to 3 dose cohorts will be selected for dose expansion stage.
In indication Expansion:
Indications will be selected to evaluate preliminary efficacy.
Intervention Type
Drug
Intervention Name(s)
HRS-3738
Intervention Description
HRS-3738 will be administrated per dose level in which the patients are assigned.
Primary Outcome Measure Information:
Title
Maximum tolerated dose (MTD)
Description
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
Title
RP2D
Description
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
Secondary Outcome Measure Information:
Title
Safety endpoints: adverse events(AEs), serious adverse events（SAEs）
Description
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.
Title
Efficacy endpoints: Overall response rate (ORR)
Description
Evaluated using Lugano 2014 criteria and IMWG criteria.
Time Frame
From Day 1 to 30 days after last dose.
Title
Efficacy endpoints: Best of response (BOR)
Description
Evaluated using Lugano 2014 criteria and IMWG criteria
Time Frame
From Day 1 to 30 days after last dose
Title
Efficacy endpoints: time to response (TTR)
Description
Evaluated using Lugano 2014 criteria and IMWG criteria.
Time Frame
From Day 1 to 30 days after last dose.
Title
Efficacy endpoints: Duration of response (DoR)
Description
Evaluated using Lugano 2014 criteria and IMWG criteria
Time Frame
From Day 1 to 30 days after last dose
Title
Efficacy endpoints: Progression-free survival (PFS)
Description
Evaluated using Lugano 2014 criteria and IMWG criteria
Time Frame
From Day 1 to 30 days after last dose
Title
Efficacy endpoints: overall survival (OS).
Description
Evaluated using Lugano 2014 criteria and IMWG criteria.
Time Frame
From Day 1 to 30 days after last dose.
Title
Cmax
Description
Maximal plasma concentration
Time Frame
From Day 1 to 30 days after last dose
Title
Tmax
Description
Time to Cmax
Time Frame
From Day 1 to 30 days after last dose
Title
AUC
Description
Area under the plasma concentration-time curve
Time Frame
From Day 1 to 30 days after last dose
Title
t1/2
Description
Terminal-phase elimination half-life
Time Frame
From Day 1 to 30 days after last dose
Title
Vz/F
Description
Apparent volume of distribution during terminal phase after non-intravenous administration
Time Frame
From Day 1 to 30 days after last dose
Title
CL/F
Description
Apparent total clearance of the drug from plasma after oral administration.
Time Frame
From Day 1 to 30 days after last dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Active multiple myeloma in accordance with IMWG criteria，or histopathologically and immunohistochemically confirmed non-Hodgkin's lymphoma in accordance with the 2016 WHO Classification of lymphoid neoplasias.
Recurred or did not alleviate after the previous treatment.
Have at least one measurable lesion.
With a life expectancy of ≥3 months.
Male or female ≥ 18 years old.
ECOG performance status of 0-1.
Subjects must voluntarily agree to participate in the trial and sign a written informed consent form.
Exclusion Criteria:
Amyloidosis, plasma cell leukemia.
Corrected serum calcium>3.4mmol/L(13.5mg/dl).
Presence of metastasis to central nervous system.
Treatment of other investigational products.
Major surgical therapy within 28 days prior to the date of signature of informed consent form, or expected major surgery during the study.
Known history of hypersensitivity to any components of HRS-3738.
Other factors that may affect the study results or lead to forced termination of the study early as judged by investigators.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wenjun Mao
Phone
+021-61053363
Email
wenjun.mao@hengrui.com
Facility Information:
Facility Name
Henan cancer Hospital
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Baijun Fang
Facility Name
Sheng Jing Hospital of China Medical University
City
Shengyang
State/Province
Liaoning
ZIP/Postal Code
110004
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei Yang
Facility Name
Zhejiang University School of Medicine The First Affiliated Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jie Jing
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Phase I Study of HRS-3738 in Recurrent and Refractory Non-Hodgkin's Lymphoma and Multiple Myeloma
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