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B-cell LymphomaPhase 1NCT04993690

A Study of LP-168 in Participants With Relapse or Refractory B-Cell Lymphoma

A Phase 1 study testing LP-168 tablet in people with B-cell Lymphoma, run by Guangzhou Lupeng Pharmaceutical Company LTD. at 3 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
Search all trials

Trial summary

This is an open-label, multi-center Phase 1/2 study of oral LP-168 in patients with CLL/SLL and NHL who have failed or are intolerant to standard of care. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
B-cell Lymphoma
What is being tested?
LP-168 tablet
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
3 sitesChina
Study dates
6 Jul 2021to 30 Sep 2027
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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Per 2017 revised WHO lymphoma classification criteria, subject must have either:
  • Diagnosed with relapsed or refractory DLBCL or FL and require treatment in the opinion of the Investigator and have received 2 lines SOC.
  • Diagnosed with relapsed or refractory non-Hodgkin's lymphoma associated with B-cell proliferation (such as CLL\ SLL \ MCL \ MZL \ WM, etc.) in need of treatment in the opinion of the Investigator and have received 1 line SOC.
  • Adequate hematologic function.
  • Adequate hepatic and renal function.
  • Ability to receive study drug therapy orally and willing to receive examinations.
  • Willingness of men and women of reproductive potential (defined as following menarche and not postmenopausal [and 2 years of non-therapy-induced amenorrhea] or surgically sterile) to observe conventional and effective birth control.

Who cannot join

  • According to the 2017 revised WHO Lymphoma Classification Criteria, patients diagnosed with the following diseases: Burkitt lymphoma or Burkitt-like lymphoma, lymphoblastic lymphoma/leukemia, and post-transplant lymphoproliferative disease(PTLD).
  • Prior malignancy (other than the disease under study) within the past 3 years, except for curatively treated basal or squamous cell skin cancer, carcinoma in situ of the cervix or breast cancer.
  • Subjects who have received the following treatments within 4 weeks or 5 half-lives before the first dose of LP-168:
  • Antitumor therapies including myelosuppressive chemotherapy, targeted therapy, biological therapy and/or immunotherapy; Any investigational treatment; Patients who have undergone major surgery, severe trauma or radiotherapy.
  • Subjects who have received the following treatments within 2 weeks before the first dose of LP-168:
  • Steroids or traditional herbal medicine for antitumor purposes; Strong and moderate CYP3A inhibitors and inducers; All drugs that may cause QTc interval prolongation or torsional tachycardia.
  • Disease states where clinical manifestations may be difficult to control, including HIV, HBV, HCV, syphilis positive or active bacterial and fungal infections; Disease affects the central nervous system with obvious symptoms; Autoimmune hemolytic anemia or Idiopathic thrombocytopenic purpura. Any gastrointestinal conditions that may severely affect the study drug absorption or pharmacokinetic parameters.
  • Subjects who cannot tolerate urine collection, venipuncture, lymph node biopsy, and bone marrow aspiration.

Trial locations and contacts

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

Jun Zhu, MD, PhD contact

+86-010-88196596

zj@bjcancer.org

Yuqin Song, MD, PhD contact

China3 sites, 3 recruiting

  • Peking University Third Hospital

    Beijing, Beijing Municipality, 100089

    Hongmei Jing, M.D., +861082265531, hongmei_jing@163.com

    Recruiting

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142

    Yuqin Song, +861088196596, SongYQ_VIP@163.com

    Recruiting

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060

    Qingqing Cai, M.D., +862087342823, caiqq@sysucc.org.cn

    Recruiting

Other trials in China

About this study

Official title: A Phase 1 Open-Label Dose Escalation and Expansion Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of LP-168 in Adult Patients With Relapse or Refractory B-Cell Lymphoma

This is an open-label, multi-center Phase 1/2 study of oral LP-168 in patients with CLL/SLL and NHL who have failed or are intolerant to standard of care.

Read the detailed description

This study includes 2 parts: phase 1a (LP-168 monotherapy dose escalation) and phase 1b (LP-168 dose expansion). In phase 1a, patients will be enrolled using an 3+3 design. The starting dose of LP-168 in oral tablet form is 100 mg/day (e.g., 100 mg once daily [QD]). Once the MTD and/or RP2D is identified in phase 1a dose escalation, enrollment will continue to phase 1b dose expansion. Cycle length will be 28 days.

Conditions
B-cell Lymphoma
Being tested
LP-168 tablet
Medical subject headings
Lymphoma, B-Cell

What participants receive

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

  • LP-168 tabletDrug

    Subjects to take LP-168 orally with 240mL water, without food, Once daily or twice daily

Study groups in NCT04993690
Study groupRoleWhat they receive
Phase I Dose EscalationExperimentalDose Escalation and determination of MTD; multiple dose levels of LP-168 to be evaluated
Receives: Drug: LP-168 tablet
Phase I Dose Expansion AExperimentalCLL/SLL patients treated with prior regimens.
Receives: Drug: LP-168 tablet
Phase I Dose Expansion BExperimentalCLL/SLL patients with no prior therapy.
Receives: Drug: LP-168 tablet
Phase I Dose Expansion CExperimentalMCL patients treated with prior regimens.
Receives: Drug: LP-168 tablet
Phase I Dose Expansion DExperimentalWM patients treated with prior regimens.
Receives: Drug: LP-168 tablet
Phase I Dose Expansion EExperimentalMZL patients treated with prior regimens.
Receives: Drug: LP-168 tablet

What is being measured

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

  1. Maximum Tolerated Dose (MTD)

    Phase 1a

    Measured: Up to 24 Months

  2. Recommended dose for Phase2 (RP2D)

    Phase Ia/Ib

    Measured: Up to 24 Months

  3. To evaluate the safety of LP-168 by assessing incidence and severity of treatment-emergent adverse events as determined by CTCAE v5.0

    Phase Ia/Ib

    Measured: Up to 24 Months

Secondary outcomes (7)

  1. Overall Response Rate

    To assess the preliminary anti-tumor activity of LP-168 based on overall response rate (ORR) as assessed by investigator and IRC.

    Measured: Up to 24 Months

  2. Progression Free Survival

    To assess the preliminary anti-tumor activity of LP-168 based on Progression free survival (PFS) as assessed by the Investigator and IRC

    Measured: Up to 24 Months

  3. Duration of Response

    To assess the preliminary anti-tumor activity of LP-168 based on Duration of response (DOR) as assessed by the Investigator and IRC.

    Measured: Up to 24 Months

  4. Pharmacokinetics (PK) As Assessed By Maximum Observed Plasma Concentration (Cmax) Of LP-168

    Phase Ia/Ib

    Measured: Up to 48 hours post dose

  5. PK As Assessed By Area Under The Plasma Concentration Time Curve From Time 0 To The Time Of The Last Quantifiable Concentration (AUC0-t) Of LP-168

    Phase Ia/Ib

    Measured: Up to 48 hours post dose

  6. PK As Assessed By Time To Maximum Observed Plasma Concentration (Tmax) Of LP-168

    Phase Ia/Ib

    Measured: Up to 48 hours post dose

  7. PK As Assessed By Terminal Half-life (t1/2) Of LP-168

    Phase Ia/Ib

    Measured: Up to 48 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 Aug 2021
  2. Study start6 Jul 2021
  3. Primary completion31 Mar 2027 (estimated)
  4. Study completion30 Sep 2027 (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
Parallel groups
Model description
Dose Escalation and determination of MTD; multiple dose levels of LP-168 to be evaluated
Masking
None (open label)
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04993690
Sponsor's protocol ID
LP-168-CN101
Status last verified
Sep 2026
First submitted
27 Jul 2021
Last updated
14 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Lin N, Cai Q, Zhou K, Sun X, Ding K, Zhang L, Jin Z, Jiang M, Peng Z, Li L, Yang W, Zhou M, Shi Y, Wang Z, Liu N, Lou Y, Shen Y, Chen Y, Tan F, Song Y, Zhu J. Rocbrutinib, a Highly Selective Fourth-Generation Covalent and Noncovalent BTK Inhibitor, in R/R Non-GCB DLBCL: Efficacy and Safety from a Phase I Study. Adv Ther. 2026 Jul 24. doi: 10.1007/s12325-026-03711-3. Online ahead of print.

    PubMed 42496861

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing LP-168 tablet in people with B-cell Lymphoma, run by Guangzhou Lupeng Pharmaceutical Company LTD. at 3 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 7 inclusion and 8 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 14 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 3 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 Jun Zhu, MD, PhD (+86-010-88196596, zj@bjcancer.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Tolerated Dose (MTD) (time frame: Up to 24 Months). 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 NCT04993690, which also lists 1 linked publication.

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 14 Sep 2026.

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