drugset / Trial / NCT07570017
A Study of Rocbrutinib Combined With R-GemOx in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma
Non-randomizedSequentialOpen-labelTreatment
Summary
This is a multicenter, open-label phase Ib study, evaluating the safety, tolerability, preliminary efficacy and PK characteristics of Rocbrutinib (LP-168) combined with R-GemOx in patients with R/R non-GCB DLBCL. Study includes dose escalation part and dose expansion part. In the dose escalation part, a classic "3+3" design will be used to assess the safety of each specified dose combination. Upon completion of a predefined escalation part, the decision on whether to proceed to the dose expansion part will be based on the safety, PK, and efficacy data of the combination regimen.
Timeline
- Start
- 2026-05-30
- Primary completion
- 2027-12-31
- Completion
- 2028-07-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Rocbrutinib | Small molecule | 150 mg | — |
| Subject | Rocbrutinib | Small molecule | 200 mg | — |
| Background | Gemcitabine | Small molecule | 1000 mg/m2 | Intravenous |
| Background | Oxaliplatin | Small molecule | 100 mg/m2 | Intravenous |
| Background | Rituximab | Monoclonal antibody | 375 mg/m2 | Intravenous |