Lp-118-Us-I01 A Phase 1/1B Study Evaluating The Safety, Pharmacokinetics, And Preliminary Efficacy Of Lp-118 In Subjects With Relapsed Or Refractory Hematological Malignancies
Posted Date: Jul 6, 2021
- Investigator: Emily Curran
- Specialties: Cancer, Oncology
- Type of Study: Drug
The primary objectives of this study are to assess the safety and tolerability profile, determine the maximum tolerated dose (MTD), and/or the recommended Phase 2 dose (RP2D) of LP-118 administered once daily as a single agent dosed orally in adult subjects with relapsed/refractory NHL, RT, MM, T-PLL (Group 1) and acute leukemia. Efficacy will be measured by Maximum Tolerated Dose, Recommended Phase 2 Dose, and Pharmacokinetic (PK) profile of LP-118: Maximum Plasma Concentration, Area Under the Curve, and Time at Maximum Concentration. The study will start at lower doses (10 mg, 20 mg) and adopt an "accelerated titration" design for these cohorts. Once the safety of the 20 mg dose level is established, it will continue dose escalation using a classic "3+3" design to establish DLT, MTD, and RP2D, starting also with an accelerated step-up dosing schedule.
Criteria:
For Group 2 Aml And All Subjects Only, White Blood Cell (Wbc) Count = 25 × 109 Cells/L At The Time Of Enrollment. Adequate Cardiac Function Defined As Shortening Fraction Of = 27% By Echocardiogram, Or Ejection Fraction Of = 50% By Echocardiogram Or Radionuclide Angiogram (Nuclear Medicine Analysis) If There Is History Of Anthracycline Exposure. Aspartate Aminotransferase (Ast) And Alanine Aminotransferase (Alt) = 3.0 × Uln; Bilirubin = 1.5 × Uln. Serum Creatinine = Uln. Absolute Neutrophil Count (Anc) = 1 X 109/L. For Group 2 Aml And All Subjects Only, White Blood Cell (Wbc) Count = 25 × 109 Cells/L At The Time Of Enrollment. Must Have An Advanced Hematologic Malignancy. No History Of Other Malignancies Within Past 12 Months That Are Active. No Live Vaccines Within 14 Days. No Heart Rate-Corrected Qt (Qtc) Interval = 480 Ms. No History Of Congenital Long Qt Syndrome Or Torsades De Pointes, Uncontrolled Or Symptomatic Arrhythmias, Congestive Heart Failure, Myocardial Infarction, Stroke Or Intracranial Hemorrhage Within 6 Months Prior To The First Dose Of Lp-118.
Keywords:
Phase 1
For More Information:
Uc Cancer Center
5135847698
cancer@uchealth.com