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.

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

∙ 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

Locations
United States
North Carolina
Duke Univerisity
RECRUITING
Durham
Ohio
University of Cincinnati
RECRUITING
Cincinnati
Ohio State University
RECRUITING
Columbus
Utah
Huntsman Cancer Institute, University of Utah
RECRUITING
Salt Lake City
Contact Information
Primary
Anna Chen, MD, PhD
yu@newavepharma.com
(206) 335-3820
Backup
Stephen Anthony, DO
s.anthony@newavepharma.com
Time Frame
Start Date: 2021-07-19
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 60
Treatments
Experimental: Dose Escalation Phase
Three to six subjects per treatment cohort will be assigned to receive sequentially higher oral doses of LP-168 on a once or twice daily schedule for 28 days, starting at a dose of 100 mg/day.
Experimental: Dose Expansion Phase
Additional subjects will be recruited to further explore the safety, tolerability, PK, and efficacy in specific subject subgroups.
Sponsors
Leads: Newave Pharmaceutical Inc

This content was sourced from clinicaltrials.gov

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