Actively Recruiting
Study of Oral LP-168 to Evaluate Safety, Tolerability, Pharmacokinetics, and Clinical Activity in Adults With Relapsed or Refractory B-cell Malignancies
Led by Newave Pharmaceutical Inc · Updated on 2026-02-13
60
Participants Needed
4
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating LP-168, a small molecule inhibitor, in adults with relapsed or refractory B-cell malignancies such as CLL/SLL, Waldenstrom Macroglobulinemia, Follicular Lymphoma, Mantle Cell Lymphoma, Marginal Zone Lymphoma, Diffuse Large B Cell Lymphoma, and Hairy Cell Leukemia. This phase I, multi-center, open-label study aims to assess the safety, tolerability, pharmacokinetics, and clinical activity of LP-168 in this patient population. The study also seeks to define the maximum tolerated dose and recommended dose for further research. Participants receive LP-168 orally either once or twice daily in escalating doses starting at 100 mg per day in cohorts of three to six subjects, with each treatment cycle lasting 28 days. After finding the maximum tolerated dose and recommended Phase 2 dose, additional subjects will join an expansion phase to further explore safety, tolerability, pharmacokinetics, and preliminary efficacy. The dose levels range up to 1000 mg once daily, with treatment continuing up to 24 months. During the study, participants will undergo regular assessments including safety evaluations, blood tests for pharmacokinetics at multiple specified days within treatment cycles, and monitoring of response to treatment. Researchers will measure maximum tolerated dose, pharmacokinetic profiles, progression-free survival, objective response rate, and duration of response. The study involves continuous monitoring for up to 24 months, with cycles of 28 days each, to evaluate the effects and safety of LP-168.
CONDITIONS
Brief Title
Study of Oral Administration of LP-168 in Patients With Relapsed or Refractory B-cell Malignancies.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Diagnosed with relapsed or refractory B-cell malignancies including WM, FL, MCL, MZL, DLBCL, HCL, CLL, or SLL based on 2016 WHO classification
- Subjects with WM, FL, MCL, DLBCL, or HCL must have received at least 2 prior systemic therapies
- Low-grade B-cell lymphomas including follicular Grade 1, 2, or 3A, marginal zone, or small lymphocytic lymphoma
- Adequate coagulation function: APTT and PT not exceeding 1.5 times upper limit of normal
- Adequate kidney function: creatinine clearance at least 60 mL/min
- Adequate liver function: AST and ALT less than or equal to 1.5 times upper limit of normal; bilirubin less than or equal to 1.5 times upper limit of normal (exceptions for Gilbert's Syndrome)
- Adequate bone marrow function independent of growth factor support with ANC at least 1000/uL (exceptions with discussion), platelet count at least 50,000/µL or 20,000/µL if thrombocytopenia is due to CLL, and hemoglobin at least 8.0 g/dL, which can be supported by transfusion
You will not qualify if you...
- Received any anti-cancer therapy including chemotherapy, immunotherapy, radiotherapy, or investigational therapy within 14 days or 5 half-lives prior to first dose, or have not recovered to Grade 1 toxicity except alopecia
- Require immediate cytoreduction (except up to two days of steroids for symptom control)
- Received steroid therapy over prednisone 20 mg/day for anti-cancer purpose within 7 days prior to first dose
- Use of strong CYP3A4 inhibitors or inducers, or strong CYP2C8 inducers/inhibitors within 7 days prior to first dose
- Use of systemic acid-reducing agents such as proton pump inhibitors (must be discontinued 7 days prior) or improper timing of H2 blockers or antacids with LP-168
- Significant ECG abnormalities including 2nd degree AV block type II, 3rd degree block, Grade 2 or higher bradycardia, or QTc interval 480 ms or higher
- Serum amylase or lipase greater than 1.5 times upper limit of normal
- History of Richter's transformation (for Phase 1a)
- Hematopoietic stem cell transplantation within 90 days or active graft-versus-host disease
- Other active malignancies within past 3 years except certain treated skin or cervical cancers
- Require anticoagulation with Warfarin
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 months, with each cycle lasting 28 days
Participants receive oral LP-168 once or twice daily in sequential 28-day cycles to evaluate safety, tolerability, and clinical activity for relapsed or refractory B-cell malignancies.
Visits at multiple time points each cycle, including Day 1, 2, 8, 9, 15, 22, and 28 for pharmacokinetic assessments
Trial Site Locations
Total: 4 locations
1
Duke Univerisity
Durham, North Carolina, United States, 27708
Actively Recruiting
2
University of Cincinnati
Cincinnati, Ohio, United States, 45221
Actively Recruiting
3
Ohio State University
Columbus, Ohio, United States, 43210
Actively Recruiting
4
Huntsman Cancer Institute, University of Utah
Salt Lake City, Utah, United States, 84112
Actively Recruiting
Research Team
A
Anna Chen, MD, PhD
S
Stephen Anthony, DO
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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