Study of LP-168 for Relapsed or Refractory B-cell Malignancies
This study is testing a new oral medication called LP-168 for people with B-cell cancers that have come back or haven't responded to previous treatments. These cancers include chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), Waldenstrom macroglobulinemia, follicular lymphoma, diffuse large B-cell lymphoma, and mantle cell lymphoma. The main goals are to find the safest and most effective dose of LP-168 and to understand how your body processes the drug. Researchers will also look at how well LP-168 works to shrink tumors and prevent the cancer from growing. About 60 people are expected to join this study.
- Study design
- This is an early-phase, open-label study where all participants receive LP-168. It involves a dose-escalation phase to find the best dose, followed by an expansion phase with more participants.
- What's involved
- You would take LP-168 by mouth once or twice daily. You will have blood tests at specific times during the first few cycles to check how your body handles the medication.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary goals of the study, such as finding the right dose, will be measured for up to 24 months, with each cycle lasting 28 days.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT04775745
Study of Oral Administration of LP-168 in Patients With Relapsed or Refractory B-cell Malignancies.
Recruiting
PHASE1Ages 18+InterventionalTreatmentNewave Pharmaceutical Inc
~60 participants
Updated 2026-02-13 on ClinicalTrials.gov
What's tested:LP-168
At a glance
Recruiting sites
4 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Maximum Tolerated Dose (MTD)
Measured over Up to 24 months, each cycle is 28 days
+4 more outcomes measured
Conditions
Where it's being run
4 sites across 3 statesOhio2
North Carolina1
Utah1
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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
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:
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.
What this trial measures
- Maximum Tolerated Dose (MTD)Up to 24 months, each cycle is 28 days
When more than 1 DLT occurs in ≤ 6 subjects in a dosing cohort, dose escalation will be stopped and this dose level will be identified as the non-tolerated dose. Doses between the non-tolerated dose and the preceding lower dose, where ≤ 1 DLT occurred, may be explored to more precisely define the MTD.
- Recommended Phase 2 dose (RP2D)Up to 24 months, each cycle is 28 days
The RP2D may be as high as the MTD or a lower dose and will be selected in discussion with the Investigators and the Sponsor based on longer term safety data, preliminary efficacy data, and PK data.
- Pharmacokinetic (PK) profile of LP-168At Cycle 1: Day 1, Day 2, Day 8, Day 9, Day 15, Day 22, Day 28; At Cycle 3: Day 28; At Cycle 6 Day 28; (each cycle is 28 days)
Maximum Plasma Concentration \[Cmax\]
- Pharmacokinetic (PK) profile of LP-168At Cycle 1: Day 1, Day 2, Day 8, Day 9, Day 15, Day 22, Day 28; At Cycle 3: Day 28; At Cycle 6 Day 28; (each cycle is 28 days
Area Under the Curve \[AUC\]
- Pharmacokinetic (PK) profile of LP-168At Cycle 1: Day 1, Day 2, Day 8, Day 9, Day 15, Day 22, Day 28; At Cycle 3: Day 28; At Cycle 6 Day 28; (each cycle is 28 days
Time at Maximum Concentration \[Tmax\]