OncoMatch/Clinical Trials/NCT04775745
Study of Oral Administration of LP-168 in Patients With Relapsed or Refractory B-cell Malignancies.
Is NCT04775745 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including LP-168 and LP-168 for cll/sll.
Treatment: LP-168 · LP-168 — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Chronic Lymphocytic Leukemia
Non-Hodgkin Lymphoma
Diffuse Large B-Cell Lymphoma
Hairy Cell Leukemia
Prior therapy
Must have received: systemic therapy
Those subjects with WM, FL, MCL, DLBCL, or HCL must have received at least 2 prior systemic therapies
Cannot have received: anti-cancer therapy
Exception: CLL subjects who come off BCR antagonists (BTK inhibitors, PI3K inhibitors, etc.) may have 2-day washout
Any anti-cancer therapy including chemotherapy, biologic or immunotherapy, radiotherapy, etc; Any investigational therapy, including targeted small molecule agents within 14 days or 5 half-lives (whichever is shorter) prior to the first dose of study drug
Cannot have received: hematopoietic stem cell transplantation
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)
Lab requirements
Blood counts
ANC ≥1000/uL (exception: if bone marrow heavily infiltrated, may use growth factor to achieve ANC eligibility); 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
Kidney function
Calculated creatinine clearance (CrCl) ≥ 60 mL/min using 24-hour CrCl OR Cockcroft-Gault formula
Liver function
AST and ALT ≤ 1.5 × ULN; Bilirubin ≤ 1.5 × ULN (except Gilbert's Syndrome, who may have a bilirubin > 1.5 × ULN, per discussion between the Investigator and the Medical Monitor)
adequate coagulation, renal, and hepatic function, per local laboratory reference ranges at Screening as follows: APTT and PT not to exceed 1.5 × ULN; CrCl ≥ 60 mL/min; AST and ALT ≤ 1.5 × ULN; Bilirubin ≤ 1.5 × ULN (except Gilbert's Syndrome); ANC ≥1000/uL (exception: if bone marrow heavily infiltrated, may use growth factor); Platelet count ≥ 50,000/µL or ≥ 20,000/ µL if thrombocytopenia due to CLL; Hemoglobin ≥8.0g/dL, can be achieved by transfusion
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Duke Univerisity · Durham, North Carolina
- University of Cincinnati · Cincinnati, Ohio
- Ohio State University · Columbus, Ohio
- Huntsman Cancer Institute, University of Utah · Salt Lake City, Utah
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