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

A Phase Ib Study to Evaluate the Safety and Efficacy of Rocbrutinib in Combination With Rituximab, Gemcitabine, Oxaliplatin (R-GemOx) in Patients With Refractory or Relapsed Diffuse Large B-cell Lymphoma

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.

Study Overview

• Status: Not yet recruiting
• Conditions: DLBCL
• Intervention / Treatment: Drug: Rocbrutinib; Drug: R-GemOx

• Study Type: Interventional
• Enrollment (Estimated): 42
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Qingqing Cai; Phone Number: 086-20-87343355; Email: caiqq@sysucc.org.cn
• Study Contact Backup: Name: Rong Tao; Phone Number: 086-210-64175590; Email: hkutao@hotmail.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510050
      • Sun Yat-sen University Cancer Center
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200032
      • Fudan University Shanghai Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients with relapsed or refractory non-GCB DLBCL.
• Have at least one measurable lesion according to the Lugano Response Criteria 2014.
• ECOG performance status 0-2 (0-1 for dose escalation part).
• Life expectancy ≥ 12 weeks.
• Adequate coagulation function, liver and kidney function, bone marrow hematopoietic function.
• No plan for autologous/allogeneic hematopoietic stem cell transplantation or chimeric antigen receptor T-cell (CAR-T) therapy.
• Toxicities from prior anti-tumor therapy have recovered to Grade ≤1 according to NCI CTCAE v5.0.
• All male subjects and female subjects of childbearing potential must strictly use medically approved contraception throughout the entire study period. All male subjects must also avoid sperm donation during the above period. For women of childbearing potential, the result of serum pregnancy test must be obtained. Women must be non-lactating
• Subjects must provide adequate tissue and blood samples for exploratory study. Participation is voluntary, requiring signed informed consent and compliance with the treatment regimen and visit schedule.

Exclusion Criteria:

• Intolerance to Rocbrutinib or any drug in the combination regimen.
• Prior treatment with a BTK-targeted therapy; prior treatment with R-GemOx.
• DLBCL transformed from an indolent lymphoma; diagnosis of high-grade or double-hit DLBCL.
• Chemotherapy, biologic therapy (except CAR-T), immunotherapy or major surgery within 4 weeks of the first dose of study treatment.
• Small molecule targeted therapy within 4 weeks or within 5 half-lives (whichever is shorter) of the first dose of study treatment.
• Herbal or proprietary Chinese medicines with antitumor activity or radiotherapy with a limited field of radiation within 7 days of the first dose of study treatment.
• History of allogeneic hematopoietic stem-cell transplantation (allo-HSCT) or other organ transplantation, or autologous HSCT (auto-HSCT) or chimeric antigen receptor T-cell (CAR-T) therapy within 90 days of the first dose of study treatment.
• Current corticosteroid therapy at a dose >20 mg/day prednisone equivalent. The prednisone-equivalent dose must have been stable for at least 4 weeks before Cycle 1 Day 1.
• Unable to discontinue prohibited medications during the study period (strong or moderate CYP3A inhibitors or inducers, P-gp inhibitors, OATP1B3-sensitive substrates, warfarin or other vitamin K antagonists).
• Known or suspected CNS involvement by lymphoma.
• Presence of peripheral neuropathy > Grade 1.
• Any severe and/or uncontrolled systemic disease, or condition affecting drug swallowing or absorption, that in the investigator's judgment makes the subject unsuitable for the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dose Level 1; Patients will receive Rocbrutinib at 150 mg once daily in combination with R-GemOx	Drug: Rocbrutinib; Patients will receive Rocbrutinib until disease progression or unacceptable toxicity; Other Names: LP-168; 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.
Experimental: Dose Level 2; Patients will receive Rocbrutinib at 200 mg once daily in combination with R-GemOx	Drug: Rocbrutinib; Patients will receive Rocbrutinib until disease progression or unacceptable toxicity; Other Names: LP-168; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
DLTs	Dose-Limiting Toxicities	At the end of Cycle 1 (the length of cycle 1 is 21 days)
MTD	Maximum Tolerated Dose	At the end of Cycle 1 (the length of cycle 1 is 21 days)
Adverse events as assessed by CTCAE v5.0		From the first administration to 28 days after the last administration

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ORR	Overall Response Rate	Up to approximately two years
TTR	Time to Response	Up to approximately two years
DoR	Duration of Response	Up to approximately two years
PFS	Progression-free Survival	Up to approximately two years
OS	Overall Survival	Up to approximately two years
Cmax	Maximum Plasma Concentration	From 1 hour prior to administration to 24 hours post-dose
Tmax	Time to Maximum Plasma Concentration	From 1 hour prior to administration to 24 hours post-dose
AUC0-t	Area Under the Plasma Concentration-Time Curve from Time Zero to Time t	From 1 hour prior to administration to 24 hours post-dose
t1/2	Half-life	From 1 hour prior to administration to 24 hours post-dose

Collaborators and Investigators

• Sponsor: Guangzhou Lupeng Pharmaceutical Company LTD.

Study record dates

Study Major Dates

• Study Start (Estimated): May 30, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): July 31, 2028

Study Registration Dates

• First Submitted: April 22, 2026
• First Submitted That Met QC Criteria: April 29, 2026
• First Posted (Actual): May 6, 2026

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: April 29, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: DLBCL; BTK inhibitor; R-GemOx
• Other Study ID Numbers: LP-168-CN109

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No