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DLBCLPhase 1NCT07570017

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

A Phase 1 study testing Rocbrutinib and R-GemOx in people with DLBCL, run by Guangzhou Lupeng Pharmaceutical Company LTD. at 2 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
DLBCL
What is being tested?
Rocbrutinib and R-GemOx
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
2 sitesChina
Study dates
25 Jun 2026to 31 Jul 2028
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Qingqing Cai contact

086-20-87343355

caiqq@sysucc.org.cn

Rong Tao contact

086-210-64175590

hkutao@hotmail.com

China2 sites, 2 recruiting

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510050

    Qingqing Cai, 086-20-87343355, caiqq@sysucc.org.cn

    Recruiting

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200032

    Rong Tao, 086-210-64175590, hkutao@hotmail.com

    Recruiting

Other trials in China

About this study

Official title: 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.

Conditions
DLBCL
Being tested
Rocbrutinib, R-GemOx
Keywords
BTK inhibitor, DLBCL, R-GemOx

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RocbrutinibDrug

    Also called LP-168

    Patients will receive Rocbrutinib until disease progression or unacceptable toxicity

  • R-GemOxDrug

    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.

Study groups in NCT07570017
Study groupRoleWhat they receive
Dose Level 1ExperimentalPatients will receive Rocbrutinib at 150 mg once daily in combination with R-GemOx
Receives: Drug: Rocbrutinib; Drug: R-GemOx
Dose Level 2ExperimentalPatients will receive Rocbrutinib at 200 mg once daily in combination with R-GemOx
Receives: Drug: Rocbrutinib; Drug: R-GemOx

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. DLTs

    Dose-Limiting Toxicities

    Measured: At the end of Cycle 1 (the length of cycle 1 is 21 days)

  2. MTD

    Maximum Tolerated Dose

    Measured: At the end of Cycle 1 (the length of cycle 1 is 21 days)

  3. Adverse events as assessed by CTCAE v5.0

    Measured: From the first administration to 28 days after the last administration

Secondary outcomes (9)

  1. ORR

    Overall Response Rate

    Measured: Up to approximately two years

  2. TTR

    Time to Response

    Measured: Up to approximately two years

  3. DoR

    Duration of Response

    Measured: Up to approximately two years

  4. PFS

    Progression-free Survival

    Measured: Up to approximately two years

  5. OS

    Overall Survival

    Measured: Up to approximately two years

  6. Cmax

    Maximum Plasma Concentration

    Measured: From 1 hour prior to administration to 24 hours post-dose

  7. Tmax

    Time to Maximum Plasma Concentration

    Measured: From 1 hour prior to administration to 24 hours post-dose

  8. AUC0-t

    Area Under the Plasma Concentration-Time Curve from Time Zero to Time t

    Measured: From 1 hour prior to administration to 24 hours post-dose

  9. t1/2

    Half-life

    Measured: From 1 hour prior to administration to 24 hours post-dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 May 2026
  2. Study start25 Jun 2026
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Jul 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
42 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07570017
Sponsor's protocol ID
LP-168-CN109
Status last verified
Sep 2026
First submitted
22 Apr 2026
Last updated
10 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Rocbrutinib and R-GemOx in people with DLBCL, run by Guangzhou Lupeng Pharmaceutical Company LTD. at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Qingqing Cai (086-20-87343355, caiqq@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

DLTs (time frame: At the end of Cycle 1 (the length of cycle 1 is 21 days)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07570017.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.

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