ClinicalTrials.gov record NCT04775745

Study of Oral Administration of LP-168 in Patients With Relapsed or Refractory B-cell Malignancies.

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 17, 2026

A Phase I, Multicenter, Open-Label, Dose-escalation Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Clinical Activity of Orally Administered LP-168 in Subjects With Relapsed or Refractory B-cell Malignancies.

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
PhasePhase 1An early-stage study, usually small, mainly to check safety, side effects and how much of a treatment can be given. Whether it works is not the main question yet.
Age18 years old and older
SexAll
LocationUnited States
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This Phase 1 study tests oral LP-168 in adults with relapsed or refractory B‑cell malignancies (CLL/SLL, Waldenstrom Macroglobulinemia, follicular lymphoma, DLBCL, mantle cell lymphoma, marginal zone lymphoma, and hairy cell leukemia). It starts with a dose‑escalation phase (3–6 subjects per cohort) giving once- or twice-daily oral doses in 28‑day cycles to find a maximum tolerated dose (MTD) and a recommended Phase 2 dose (RP2D), then opens a cohort expansion at the RP2D. The study will measure plasma drug levels (pharmacokinetics) and collect early data on clinical activity such as progression‑free survival, objective response rate, and duration of response.

What it is studying. The study is testing the safety and tolerability of orally given LP-168, the appropriate dose to use in future research (MTD/RP2D), the drug's pharmacokinetics, and its preliminary clinical activity in relapsed or refractory B‑cell malignancies.

What the researchers hope to learn. Scientific goals are to define LP-168 safety and tolerability, determine the maximum tolerated dose and recommended Phase 2 dose, characterize pharmacokinetics, and gather preliminary efficacy data (progression‑free survival, objective response rate, duration of response) to inform further studies.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

This is a phase I, multi-center, open-label, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics and clinical activity of LP-168 in subjects with relapsed or refractory B-cell malignancies. LP-168 is a small molecule inhibitor.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Drug
  • LP-168

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

Inclusion criteria

  • A subject will be eligible for study participation if he/she meets the following criteria:
  • Subjects are eligible with B-cell malignancies, WM, FL, MCL, MZL, DLBCL, HCL, CLL, SLL, based upon 2016 updated WHO classification. Those subjects with WM, FL, MCL, DLBCL, or HCL must have received at least 2 prior systemic therapies.
  • Low-grade B-cell lymphomas as follicular Grade 1, 2, or 3A, marginal zone or small lymphocytic lymphoma.
  • Subject must have adequate coagulation, renal, and hepatic function, per local laboratory reference ranges at Screening as follows:
  • Activated partial thromboplastin time (APTT) and prothrombin time (PT) not to exceed 1.5 × ULN
  • Calculated creatinine clearance (CrCl) ≥ 60 mL/min using 24-hour CrCl OR Cockcroft-Gault formula.
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 1.5 ×ULN; Bilirubin ≤ 1.5 × ULN (except subjects with Gilbert's Syndrome, who may have a bilirubin > 1.5 × ULN, per discussion between the Investigator and the Medical Monitor).
  • Subjects must have adequate bone marrow independent of growth factor support per local laboratory reference range at screening as follows:
  • Absolute Neutrophil Count (ANC) ≥1000/uL;
  • An exception is for subjects with an ANC<1000/uL and bone marrow heavily infiltrated with underlying disease (approximately 60% or more) may use growth factor to achieve the ANC eligibility criteria per discussion between the Investigator and the Medical Monitor.
  • Platelet count ≥ 50,000/µL - OR - Platelet count ≥ 20,000/ µL if thrombocytopenia is clearly due to CLL disease under study (per Investigator discretion)
  • Hemoglobin ≥8.0g/dL, and can be achieved by transfusion

Exclusion criteria

  • A subject will not be eligible for study participation if he/she meets any of the following criteria.
  • Subject has received any of the following therapies within 14 days or 5 half-lives (whichever is shorter) prior to the first dose of study drug, or has not recovered to ≤ Grade 1 clinically significant adverse effect(s)/toxicity(s) of the previous therapy (other than alopecia):
  • Any anti-cancer therapy including chemotherapy, biologic or immunotherapy, radiotherapy, etc;
  • Any investigational therapy, including targeted small molecule agents.
  • For CLL subjects who come off BCR antagonists (BTK inhibitors, PI3K inhibitors, etc.) treatment, allow washout for 2 days as these subjects progress quickly after treatment discontinuation and then remain eligible (steroids may be given during these two days to allow disease control).
  • Subjects who require immediate cytoreduction. However, subjects may receive up to two days of steroids for symptoms of impending organ impairment and remain eligible.
  • Subject has received the following medications or therapies within 7 days prior to the first dose of study drug:
  • Steroid therapy (at dosages equivalent to prednisone >20 mg/day) for anti-neoplastic intent (except as noted in exclusion criteria #3);
  • Cytochrome P450, family 3, subfamily A (CYP3A4) strong inhibitors and strong CYP2C8 inducers/inhibitors.
  • Potent CYP3A4 inducers such as rifampin, carbamazepine, phenytoin, and St. John's wort.
  • Subjects require treatment with systemic acid-reducing agents including H-2-receptor antagonists and proton pump inhibitors with the following exceptions:
  • Proton pump inhibitors should be discontinued at least 7 days prior and held throughout the study
  • If concurrent use of an H2 blocking agent is necessary, it must be administered only between 2 and 3 hours after the dose of LP-168. If not taken during this time, the dose of H2 blocking agents should not be taken again until 2-3 hours after the next dose of LP-168.
  • If concurrent use of a local antacid is necessary, it must be administered 2 or more hours before and/or 2 or more hours after the dose of LP-168.
  • Subject has significant screening electrocardiogram (ECG) abnormalities including. 2nd degree AV block type II 3rd degree block, Grade 2 or higher bradycardia, and corrected QT interval (QTc) ≥ 480ms.
  • Serum amylase > 1.5 × ULN or serum lipase > 1.5 × ULN.
  • Subject has any history of Richter's transformation for Phase 1a portion of the trial.
  • Subjects who have undergone autologous/allogeneic hematopoietic stem cell transplantation (HSCT) therapy within 90 days of the first dose of LP-168, or patients on immunosuppressive therapy post-HSCT at the time of Screening, or currently with clinically significant graft-versus-host disease (GVHD) as per treating physician (Patients in relapse after allogeneic transplantation must be off treatment with systemic immunosuppressive agents for at least 4 weeks. The use of topical steroids and/or up to 20 mg/day prednisone or equivalent systemic steroids for ongoing GVHD is permitted.
  • Subject has a history of other active malignancies other than B-cell malignancies within the past 3 years prior to study entry, with the exception of:
  • Adequately treated in situ carcinoma of the cervix uteri;
  • Basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin;
  • Previous malignancy confined and surgically resected (or treated with other modalities) with curative intent.
  • Subject requires anticoagulation with Warfarin.

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Detailed description from the registry

The primary objectives for the study are to assess the safety and tolerability profile, determine the maximum tolerated dose (MTD), and/or the recommended Phase 2 dose (RP2D) of LP-168 administered once or twice daily as a single agent dosed orally in adult subjects with relapsed/refractory B-cell Malignancies (CLL/SLL, WM, FL, MCL, MZL, DLBCL, HCL); and to characterize the pharmacokinetics (PK) profile of LP-168 in adult subjects with relapsed/refractory B-cell Malignancies (CLL/SLL, WM, FL, MCL, MZL, DLBCL, HCL). Secondary objectives of the study are to evaluate preliminary efficacy regarding the effect of LP-168 on progression-free survival (PFS), objective response rate (ORR), and duration of response (DOR) in adult subjects with relapsed/refractory B-cell Malignancies (CLL/SLL, WM, FL, MCL, MZL, DLBCL, HCL). Once the MTD is declared and the RP2D is established, additional subjects will be enrolled in a cohort expansion phase (Phase 1b).

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participants take the study drug LP-168 by mouth once or twice daily in 28‑day treatment cycles; doses are given sequentially to small groups in a dose‑escalation stage. Blood samples for pharmacokinetic (PK) testing are taken on Cycle 1 Days 1, 2, 8, 9, 15, 22, and 28, and on Cycle 3 Day 28 and Cycle 6 Day 28. After a recommended Phase 2 dose (RP2D) is chosen, additional participants may join a dose‑expansion group and receive LP-168 at that dose. Treatment and assessments occur in 28‑day cycles and may continue for up to 24 months.

How the study is structured. This is a multicenter, open-label Phase 1 treatment trial with sequential, non-randomized dose escalation followed by a cohort expansion (Phase 1b). Participants receive LP-168 by mouth once or twice daily in 28‑day treatment cycles; cohorts of 3–6 subjects receive progressively higher doses starting at 100 mg/day to identify the MTD and RP2D. After the RP2D is determined, additional subjects are enrolled to further evaluate safety, pharmacokinetics, and early efficacy at that dose. There is no masking.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • The registry lists this study under CLL/SLL; Waldenstrom Macroglobulinemia; Follicular Lymphoma; Diffuse Large B Cell Lymphoma; Mantle Cell Lymphoma; Marginal Zone Lymphoma; Hairy Cell Leukemia. Does it apply to my diagnosis?
  • This is an early-phase study, mainly about safety and dose. What is already known about this treatment?
  • The listed sites are in United States. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on Waldenström macroglobulinemia

Clinical trials63 trials listed for Waldenström macroglobulinemiaEvery trial the registry lists for Waldenström macroglobulinemia, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in Waldenström macroglobulinemia researchLatest monthly update: September 2026. Includes: Upfront treatment outcomes. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
Jul 19, 2021
Primary completion
Dec 31, 2027 (estimated)
Study completion
Dec 31, 2027 (estimated)
Target enrollment
60 participants (estimated)
Last updated on registry
Feb 13, 2026
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Newave Pharmaceutical Inc

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (4)

  • Duke UniverisityRecruiting

    Durham, North Carolina, 27708 · United States

  • University of CincinnatiRecruiting

    Cincinnati, Ohio, 45221 · United States

  • Ohio State UniversityRecruiting

    Columbus, Ohio, 43210 · United States

  • Huntsman Cancer Institute, University of UtahRecruiting

    Salt Lake City, Utah, 84112 · United States

Terms used on this page · explanations by MedicalUpdates.ai

open-label
No masking is used, so the assigned intervention is not deliberately hidden from participants or study staff.
dose-escalation
Groups of participants receive increasing doses of a treatment, one group after another, to find a dose that can be given safely.
pharmacokinetics
How the body absorbs, distributes, breaks down and removes a drug. It is studied by measuring drug levels or related substances at set times after a dose.
relapsed or refractory
A condition that has not responded to a treatment. 'Relapsed' means it responded and then came back; 'refractory' means it did not respond in the first place.
at Screening
The checks done before enrolment to see whether a person qualifies, such as tests, scans or a review of medical history.
× ULN
The highest value of a blood test that a laboratory considers normal. Criteria such as '≤ 3 × ULN' mean the result must be no more than three times that value.
creatinine clearance
A measure of kidney function, calculated from a blood creatinine level together with age, weight and sex.
Absolute Neutrophil Count
The number of neutrophils, a type of white blood cell that fights infection, in a blood sample. Studies often require it to be above a set level.
eligibility criteria
The rules the study team uses to decide who may take part. They are usually split into inclusion criteria and exclusion criteria.
5 half-lives
The time it takes for the amount of a drug in the body to fall by half. 'Five half-lives' is often used as the point at which a previous drug has essentially left the body.
study drug
A treatment that is being tested and has not been approved for this use. It may be approved for a different condition. Being studied does not mean it works or is available outside the study.
washout
A period during which a participant stops a previous treatment before starting the study treatment, so the earlier treatment does not affect the results.
prednisone
Steroid medicines, such as prednisone, that reduce inflammation. Studies often require a stable dose at entry or measure whether the study treatment allows the dose to be reduced.
exclusion criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
electrocardiogram
A recording of the heart's electrical activity. QTc is one measurement from it; some drugs are avoided if it is prolonged.
HSCT
A procedure that replaces blood-forming cells after high-dose treatment. 'Autologous' uses the person's own cells collected beforehand; 'allogeneic' uses cells from a donor.
immunosuppressive
A medicine that reduces the activity of the immune system. Studies of autoimmune conditions often require a stable dose, a prior failure, or a washout of such medicines.
relapse
A condition that improved with treatment and has since returned or worsened.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
maximum tolerated dose
The highest dose found in a dose-escalation study that can be given without too many dose-limiting side effects.
recommended Phase 2 dose
The dose chosen at the end of a phase 1 study for testing in later studies, based on safety and other measurements.
progression-free survival
The length of time during and after treatment that a person lives without the condition getting worse, as defined by the study.
cohort
A group of people who share a characteristic, such as a diagnosis, and are studied together. 'Prospective' means they are followed forward from enrolment; 'retrospective' means existing records are reviewed.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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