Lp-168-Us-I01 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
Posted Date: Aug 24, 2021
- Investigator: John Byrd
- Specialties: Cancer, Oncology
- Type of Study: Drug
The purpose of this study is 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. This study will consist of two experimental arms. Efficacy will be determined by the maximum tolerated dose, recommended phase 2 dose, and the pharmacokinetic profile of Lp-168.
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. 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. Absolute Neutrophil Count (Anc) =1000/Ul. Platelet Count = 50,000/Μl - Or - Platelet Count = 20,000/ Μl If Thrombocytopenia Is Clearly Due To Cll Disease Under Study. No Subjects Who Require Immediate Cytoreduction. No Serum Amylase > 1.5 × Uln Or Serum Lipase > 1.5 × Uln. No Subject That Has Any History Of Richter's Transformation For Phase 1A Portion Of The Trial.
Malignancy, Phase 1
For More Information:
Uc Cancer Center