CLL/SLL Clinical Trial
Official title:
APG-2575CU101, A Phase Ib Study of APG-2575 as a Single Agent or in Combination With Other Therapeutic Agents in Patients With Relapsed and/or Refractory Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL
Assess the safety and tolerability, identify dose-limiting toxicities (DLT) and determine the maximum tolerated dose (MTD) / recommended phase 2 dose (RP2D) of APG-2575.
The study will be conducted in two (2) parts and each part will consist of a ramp-up period, dose escalation and dose expansion portions. The duration of the ramp-up period will depend on the dose schedule being tested and will be conducted for both monotherapy and combination therapy. The ramp-up will consist of treatment with APG-2575 given once a day starting at 20 mg on Day 1, 50 mg on Day 2, 100 mg on Day 3, 200 mg on Day 4, 400 mg on Day 5¸ 600 mg on Day 6, 800 mg on Day 7, 1000 mg on Day 8 and 1200 mg on Day 9. Scheduled maximum cohort doses for evaluation will start at 200 mg of APG-2575 to a maximum of 1200 mg of APG-2575. Consequently, patients with a scheduled maximum dose of 200 mg will have a 3-day ramp-up period, those scheduled at 400 mg, a 4-day ramp-up, and those scheduled at 600 mg, a 5-day ramp-up, etc, see Figure 1. Part 1 will study APG-2575 at different dose levels as monotherapy using a 3+3 dose escalation design with dose expansion at RP2D. Part 2 will be combination of APG-2575 with rituximab or acalabrutinib or voruciclib Part 2 will be a 3+3 dose escalation of combination APG-2575 plus rituximab or acalabrutinib or voruciclib. Expansion cohorts at RP2D for the respective combinations will be conducted to further evaluate safety and anticancer activity ;
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