Recurrent and Refractory Non-Hodgkin's Lymphoma and Multiple Myeloma
Conditions
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.
Interventions
DRUGHRS-3738
HRS-3738 will be administrated per dose level in which the patients are assigned.
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Single arm study of HRS-3738
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum tolerated dose (MTD) | From Day 1 to Day 28 | Incidence and category of dose limiting toxicities (DLTs) during the first 28-day cycle of HRS-3738 treatment. |
| RP2D | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety endpoints: adverse events(AEs), serious adverse events（SAEs） | From Day 1 to 30 days after last dose. | Assess safety and tolerability of HRS-3738 by way of adverse events (CTCAE v5.0). |
| Efficacy endpoints: Overall response rate (ORR) | From Day 1 to 30 days after last dose. | Evaluated using Lugano 2014 criteria and IMWG criteria. |
| Efficacy endpoints: Best of response (BOR) | From Day 1 to 30 days after last dose | Evaluated using Lugano 2014 criteria and IMWG criteria |
| Efficacy endpoints: time to response (TTR) | From Day 1 to 30 days after last dose. | Evaluated using Lugano 2014 criteria and IMWG criteria. |
| Efficacy endpoints: Duration of response (DoR) | From Day 1 to 30 days after last dose | Evaluated using Lugano 2014 criteria and IMWG criteria |
| Efficacy endpoints: Progression-free survival (PFS) | From Day 1 to 30 days after last dose | Evaluated using Lugano 2014 criteria and IMWG criteria |
| Efficacy endpoints: overall survival (OS). | From Day 1 to 30 days after last dose. | Evaluated using Lugano 2014 criteria and IMWG criteria. |
| Cmax | From Day 1 to 30 days after last dose | Maximal plasma concentration |
| Tmax | From Day 1 to 30 days after last dose | Time to Cmax |
| AUC | From Day 1 to 30 days after last dose | Area under the plasma concentration-time curve |
| t1/2 | From Day 1 to 30 days after last dose | Terminal-phase elimination half-life |
| Vz/F | From Day 1 to 30 days after last dose | Apparent volume of distribution during terminal phase after non-intravenous administration |
| CL/F | From Day 1 to 30 days after last dose | Apparent total clearance of the drug from plasma after oral administration. |
Countries
China
Outcome results
None listed