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)
Ascentage Pharma Group Inc.
Summary
Assess the safety and tolerability, identify dose-limiting toxicities (DLT) and determine the maximum tolerated dose (MTD) / recommended phase 2 dose (RP2D) of lisaftoclax.
Description
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 lisaftoclax 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, and 1,000 mg on Day 8. Scheduled maximum cohort doses for evaluation will start at 400 mg of lisaftoclax to a ma…
Eligibility
- Age range
- 18–85 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. ≥18 years of age. 2. Histologically confirmed chronic lymphocytic leukemia (CLL) or small lymphocytic leukemia (SLL) according to the 2018 international workshop (IW) CLL criteria who must have relapsed or be refractory to at least one prior therapy for CLL/SLL and require treatment by 2018 IWCLL criteria. In addition, lisaftoclax (600 mg) plus acalabrutinib combination cohort may include patients who are: (1) treatment-naïve, or (2) refractory to venetoclax. 3. Eastern Cooperative Oncology Group (ECOG) ≤ 2. 4. Patient must have objectively documented evidence of diseas…
Interventions
- DrugLisaftoclax
Lisaftoclax investigation drug in ramp up dosing
Locations (9)
- City of HopeDuarte, California
- Mayo ClinicJacksonville, Florida
- Dana Farber Cancer InstituteBoston, Massachusetts
- Novant HealthCharlotte, North Carolina
- Gabrail Cancer CenterCanton, Ohio
- Cleveland ClinicCleveland, Ohio