Clinical trial NCT05363800: 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
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Recurrent and Refractory Non-Hodgkin's Lymphoma and Multiple Myeloma
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-05-06
Enrollment: 198
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single arm study of HRS-3738
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. 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.
2. Recurred or did not alleviate after the previous treatment.
3. Have at least one measurable lesion.
4. With a life expectancy of ≥3 months.
5. Male or female ≥ 18 years old.
6. ECOG performance status of 0-1.
7. Subjects must voluntarily agree to participate in the trial and sign a written informed consent form.

Exclusion Criteria:

1. Amyloidosis, plasma cell leukemia.
2. Corrected serum calcium\>3.4mmol/L(13.5mg/dl).
3. Presence of metastasis to central nervous system.
4. Treatment of other investigational products.
5. Major surgical therapy within 28 days prior to the date of signature of informed consent form, or expected major surgery during the study.
6. Known history of hypersensitivity to any components of HRS-3738.
7. Other factors that may affect the study results or lead to forced termination of the study early as judged by investigators.

Primary outcomes:
measure: Maximum tolerated dose (MTD)
timeFrame: From Day 1 to Day 28
measure: RP2D
timeFrame: From Day 1 to Day 28
Secondary outcomes:
measure: Safety endpoints: adverse events(AEs), serious adverse events（SAEs）
timeFrame: From Day 1 to 30 days after last dose.
measure: Efficacy endpoints: Overall response rate (ORR)
timeFrame: From Day 1 to 30 days after last dose.
measure: Efficacy endpoints: Best of response (BOR)
timeFrame: From Day 1 to 30 days after last dose
measure: Efficacy endpoints: time to response (TTR)
timeFrame: From Day 1 to 30 days after last dose.
measure: Efficacy endpoints: Duration of response (DoR)
timeFrame: From Day 1 to 30 days after last dose
measure: Efficacy endpoints: Progression-free survival (PFS)
timeFrame: From Day 1 to 30 days after last dose
measure: Efficacy endpoints: overall survival (OS).
timeFrame: From Day 1 to 30 days after last dose.
measure: Cmax
timeFrame: From Day 1 to 30 days after last dose
measure: Tmax
timeFrame: From Day 1 to 30 days after last dose
measure: AUC
timeFrame: From Day 1 to 30 days after last dose
measure: t1/2
timeFrame: From Day 1 to 30 days after last dose
measure: Vz/F
timeFrame: From Day 1 to 30 days after last dose
measure: CL/F
timeFrame: From Day 1 to 30 days after last dose
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Henan cancer Hospital
state: Henan
city: Shengyang
country: China
facility: Sheng Jing Hospital of China Medical University
state: Liaoning
city: Hangzhou
country: China
facility: Zhejiang University School of Medicine The First Affiliated Hospital
state: Zhejiang
Study officials:
References: