Study of Oral Administration of LP-168 in Patients With Relapsed or Refractory B-cell Malignancies.
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- CLL/SLL
- Diffuse Large B Cell Lymphoma
- Follicular Lymphoma
- Hairy Cell Leukemia
- Mantle Cell Lymphoma
- Marginal Zone Lymphoma
- Waldenstrom Macroglobulinemia
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: Non-RandomizedIntervention Model: Sequential AssignmentIntervention Model Description: A classic "3+3" design will be used to establish the dose-limiting toxicity (DLT), MTD, and RP2D. 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 (a "Cycle"), starting at a dose of 100 mg/day. Once all subjects in a given cohort have reached Cycle 1 Day 28, these data will be reviewed by the Safety Review Committee (SRC) for decisions on dose escalation for a new dose cohort. Subjects will receive once-daily or twice-daily oral dose of LP-168 until disease progression, unacceptable toxicity, or a clinical observation satisfying another criterion for withdrawal from treatment is noted.Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
The primary objectives for the 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-168 administered once or twice daily as a single agent dosed orally in adult subjects with relapsed/refractory B-cell M...
The primary objectives for the 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-168 administered once or twice daily as a single agent dosed orally in adult subjects with relapsed/refractory B-cell Malignancies (CLL/SLL, WM, FL, MCL, MZL, DLBCL, HCL); and to characterize the pharmacokinetics (PK) profile of LP-168 in adult subjects with relapsed/refractory B-cell Malignancies (CLL/SLL, WM, FL, MCL, MZL, DLBCL, HCL). Secondary objectives of the study are to evaluate preliminary efficacy regarding the effect of LP-168 on progression-free survival (PFS), objective response rate (ORR), and duration of response (DOR) in adult subjects with relapsed/refractory B-cell Malignancies (CLL/SLL, WM, FL, MCL, MZL, DLBCL, HCL). Once the MTD is declared and the RP2D is established, additional subjects will be enrolled in a cohort expansion phase (Phase 1b).
Tracking Information
- NCT #
- NCT04775745
- Collaborators
- Not Provided
- Investigators
- Not Provided
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