Actively Recruiting
Study of Oral Administration of LP-168 in Patients With Relapsed or Refractory B-cell Malignancies.
Led by Newave Pharmaceutical Inc · Updated on 2026-02-13
60
Participants Needed
4
Research Sites
336 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 with relapsed or refractory B-cell malignancies including CLL, SLL, WM, FL, MCL, MZL, DLBCL, and HCL
- For WM, FL, MCL, DLBCL, or HCL, must have received at least 2 prior systemic therapies
- Low-grade B-cell lymphomas such as follicular Grade 1, 2, or 3A, marginal zone, or small lymphocytic lymphoma
- Adequate coagulation: APTT and PT not exceeding 1.5 times the upper limit of normal
- Adequate kidney function with creatinine clearance 60 mL/min or higher
- Adequate liver function with AST and ALT at or below 1.5 times the upper limit of normal; bilirubin at or below 1.5 times upper limit except Gilbert's Syndrome
- Adequate bone marrow function including ANC 1000/uL or higher (exceptions apply), platelet count 50,000/uL or higher (or 20,000/uL if due to CLL), and hemoglobin 8.0 g/dL or higher which can be achieved by transfusion
You will not qualify if you...
- Received anti-cancer therapy, investigational therapy, or immunotherapy within 14 days or 5 half-lives before starting study drug without recovery to mild side effects
- Require immediate cytoreduction except up to two days of steroids for organ impairment symptoms
- Received steroids above 20 mg/day prednisone equivalent for cancer treatment within 7 days before study drug
- Use of strong CYP3A4 inhibitors or inducers, strong CYP2C8 inducers/inhibitors, or certain other medications within 7 days before study drug
- Require systemic acid-reducing agents except as allowed with specific timing restrictions
- Significant ECG abnormalities such as second or third degree AV block, grade 2 or higher bradycardia, or prolonged QTc
- Elevated serum amylase or lipase above 1.5 times upper limit of normal
- History of Richter's transformation (for Phase 1a)
- Stem cell transplant within 90 days, ongoing immunosuppressive therapy, or active graft-versus-host disease
- Other active cancers within past 3 years except certain treated skin or cervical cancers
- Require anticoagulation with Warfarin
AI-Screening
AI-Powered Screening
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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
CONTACT
S
Stephen Anthony, DO
CONTACT
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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