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A Study of Rocbrutinib Combined With R-GemOx in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma

NCT07570017 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2026-05-06

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Rocbrutinib

Patients will receive Rocbrutinib until disease progression or unacceptable toxicity

DRUG

R-GemOx

Patients will receive 6 cycles every 21 days of R-GemOx. Rituximab 375mg/m2 i.v. on day 1 of every cycle. GemOx (gemcitabine 1000mg/m2 plus oxaliplatin 100mg/m2) i.v. on day 2 of each cycle.

Sponsors & Collaborators

  • Guangzhou Lupeng Pharmaceutical Company LTD.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-30
Primary Completion
2027-12-31
Completion
2028-07-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07570017 on ClinicalTrials.gov