A Study Evaluating APG-115 as a Single Agent or in Combination With APG-2575 in Subjects With T-PLL
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- T-Prolymphocytic Leukemia
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: Non-RandomizedIntervention Model: Sequential AssignmentIntervention Model Description: The study consists of Part 1 APG-115 as monotherapy and Part 2 APG-2575 in combination with APG-115 (APG-115 dose fixed). APG-115 and APG-2575 will be orally administrated on 28-day cycles. Totally 12-18 participants will be enrolled using a 3+3 dose escalation design. Patients receive APG-115 orally once every day (QD) with meal on Days 1 to 5, 23 days off on the 28-day cycles.The recommended dose of APG-115 used in combination with APG-2575 will be determined based on the data from Part 1 after discussion between the sponsor and investigators. APG-2575 will be administered orally once every day (QD) with meal (low fat meal preferred) in a 28-day cycle following a daily ramp-up schedule. Dose escalation uses a standard 3+3 design starting from 400 mg to 800 mg (400 mg, 600 mg, 800 mg). APG-115 will be given at a fixed dose and started after the daily ramp-up of APG-2575 is completed.Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
In Part 1, 12-18 participants will be enrolled using a 3+3 dose escalation design. Patients receive APG-115 orally once every day (QD) with meal on Days 1 to 5, and 23 days off in the 28-day cycles. In Part 2, the recommended starting dose of APG-115 in combination with APG-2575 in Part 2 will be de...
In Part 1, 12-18 participants will be enrolled using a 3+3 dose escalation design. Patients receive APG-115 orally once every day (QD) with meal on Days 1 to 5, and 23 days off in the 28-day cycles. In Part 2, the recommended starting dose of APG-115 in combination with APG-2575 in Part 2 will be determined by pooling available dose, PK, pharmacodynamics (PD), safety, and efficacy data of Part I, and the consequent results of conducting an integrated dose-response and exposure-response analyses on the data from Part 1, after discussion between the sponsor and investigators. APG-2575 will be administered orally once every day (QD) with meal (low fat meal preferred) in a 28-day cycle following a daily ramp-up schedule.
Tracking Information
- NCT #
- NCT04496349
- Collaborators
- Not Provided
- Investigators
- Study Chair: Yifan Zhai, MD, PhD Ascentage Pharma Group Inc.
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