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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HRS-3738 | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS-3738 | Drug | HRS-3738 will be administrated per dose level in which the patients are assigned. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum tolerated dose (MTD) | Incidence and category of dose limiting toxicities (DLTs) during the first 28-day cycle of HRS-3738 treatment. | 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. | From Day 1 to Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety endpoints: adverse events(AEs), serious adverse events(SAEs) | Assess safety and tolerability of HRS-3738 by way of adverse events (CTCAE v5.0). | From Day 1 to 30 days after last dose. |
| Efficacy endpoints: Overall response rate (ORR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henan cancer Hospital | Zhengzhou | Henan | 450000 | China | ||
| Sheng Jing Hospital of China Medical University |
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| ID | Term |
|---|---|
| D012008 | Recurrence |
| D008228 | Lymphoma, Non-Hodgkin |
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008223 | Lymphoma |
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Single arm study of HRS-3738
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Evaluated using Lugano 2014 criteria and IMWG criteria.
| From Day 1 to 30 days after last dose. |
| Efficacy endpoints: Best of response (BOR) | Evaluated using Lugano 2014 criteria and IMWG criteria | From Day 1 to 30 days after last dose |
| Efficacy endpoints: time to response (TTR) | Evaluated using Lugano 2014 criteria and IMWG criteria. | From Day 1 to 30 days after last dose. |
| Efficacy endpoints: Duration of response (DoR) | Evaluated using Lugano 2014 criteria and IMWG criteria | From Day 1 to 30 days after last dose |
| Efficacy endpoints: Progression-free survival (PFS) | Evaluated using Lugano 2014 criteria and IMWG criteria | From Day 1 to 30 days after last dose |
| Efficacy endpoints: overall survival (OS). | Evaluated using Lugano 2014 criteria and IMWG criteria. | From Day 1 to 30 days after last dose. |
| Cmax | Maximal plasma concentration | From Day 1 to 30 days after last dose |
| Tmax | Time to Cmax | From Day 1 to 30 days after last dose |
| AUC | Area under the plasma concentration-time curve | From Day 1 to 30 days after last dose |
| t1/2 | Terminal-phase elimination half-life | From Day 1 to 30 days after last dose |
| Vz/F | Apparent volume of distribution during terminal phase after non-intravenous administration | From Day 1 to 30 days after last dose |
| CL/F | Apparent total clearance of the drug from plasma after oral administration. | From Day 1 to 30 days after last dose |
| Shengyang |
| Liaoning |
| 110004 |
| China |
| Zhejiang University School of Medicine The First Affiliated Hospital | Hangzhou | Zhejiang | 310003 | China |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D054219 | Neoplasms, Plasma Cell |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006474 | Hemorrhagic Disorders |