Study of APG-2575 as a Single Agent or in Combination With Other Therapeutic Agents for CLL/SLL
ConditionCLL/SLL
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-85
SponsorAscentage Pharma Group Inc.
About this trial
Assess the safety and tolerability, identify dose-limiting toxicities (DLT) and determine the maximum tolerated dose (MTD) / recommended phase 2 dose (RP2D) of lisaftoclax.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
≥18 years of age.
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.
Eastern Cooperative Oncology Group (ECOG) ≤ 2.
Patient must have objectively documented evidence of disease progression prior to study entry such as: escalating lymphocytes count with an increase > 50% over a period of two months or doubling time in less than 6 months; enlarging adenopathy or splenomegaly; increasing cytopenias; clinical B symptoms -night sweats, fatigue, > 1% weight loss in 6 months, fevers > 100.50F for ≥ one month without infection.
Disqualifiers
Patient has undergone allogeneic stem cell transplant < 90 days.
Patient has active graft-versus-host disease or require immunosuppressive therapy.
Patient has undergone CAR-T cell therapy < 30 days.
Richter's Syndrome (patients with previously treated Richter's syndrome will be permitted if they are in remission).
Trial design
Design model
Parallel
Treatments tested in this trial
Lisaftoclax
DrugLisaftoclax investigation drug in ramp up dosing
Treatment groups
144 Participants
are divided into 4 treatment groupsGroup A: Lisaftoclax 400mgExperimental treatment 1 intervention
Group B: Lisaftoclax 600mgExperimental treatment 1 intervention
Group C: Lisaftoclax 800mgExperimental treatment 1 intervention
Group D: Lisaftoclax 1000mgExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Primary Toxicity Endpoint: dose limiting toxicity (DLT)
DLT will be defined based on the rate of drug-related grade 3-5 adverse events experienced within the first 6 weeks (2 cycles) of study treatment. These will be assessed via CTCAE version 5.0
Time frame
42 days2
Maximally tolerated dose (MTD)
MTD will be determined based on DLTs observed during the first 6 weeks (2 cycles) of study treatment
Time frame
42 daysSponsors and contacts
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Source ClinicalTrials.gov