Clinical trial · Interventional
Phase I Study of HRS-3738 in Recurrent and Refractory Non-Hodgkin's Lymphoma and Multiple Myeloma
NCT05363800CI-TRIAL-00113866active not recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Recurrent and Refractory Non-Hodgkin's Lymphoma and Multiple Myeloma | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HRS-3738 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- HRS-3738
- 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.
- interventionNames
- Drug: HRS-3738
Primary outcomes (2)
- measure
- Maximum tolerated dose (MTD)
- timeFrame
- From Day 1 to Day 28
- description
- Incidence and category of dose limiting toxicities (DLTs) during the first 28-day cycle of HRS-3738 treatment.
- measure
- RP2D
- timeFrame
- From Day 1 to Day 28
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.