Actively Recruiting
Study of APG-2575 as a Single Agent or in Combination With Other Therapeutic Agents for CLL/SLL
Led by Ascentage Pharma Group Inc. · Updated on 2025-04-10
144
Participants Needed
9
Research Sites
382 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Assess the safety and tolerability, identify dose-limiting toxicities (DLT) and determine the maximum tolerated dose (MTD) / recommended phase 2 dose (RP2D) of lisaftoclax.
CONDITIONS
Official Title
Study of APG-2575 as a Single Agent or in Combination With Other Therapeutic Agents for CLL/SLL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older
- Histologically confirmed CLL or SLL with relapse or refractory status after at least one prior therapy
- Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less
- Documented disease progression before study entry
- Adequate bone marrow function independent of growth factor
- Adequate kidney and liver function as defined by laboratory criteria
- Negative pregnancy test for females of childbearing potential before treatment
- Use of effective birth control methods for females and non-sterile males during and 90 days after treatment
- Male patients must avoid sperm donation during treatment and for 90 days after
- Ability to understand and sign informed consent
- Willingness and ability to comply with study procedures and follow-up
You will not qualify if you...
- Allogeneic stem cell transplant within 90 days
- Active graft-versus-host disease or need for immunosuppressive therapy
- CAR-T cell therapy within 30 days
- Richter's Syndrome unless in remission
- Prior anti-BCL-2 treatment except under specific conditions
- For combination therapy cohort: intolerance to acalabrutinib, need for proton pump inhibitors, or warfarin use
- Active infections including HIV, hepatitis B, hepatitis C, or COVID-19
- Known central nervous system involvement
- Recent or recurrent malignancies within 2 years except certain skin or cervical/breast cancers
- Recent use of other investigational agents or anti-cancer therapies
- Pregnancy or breastfeeding
- Recent use of high-dose steroids or certain CYP3A inhibitors/inducers
- Radiation within 14 days before study
- Unresolved toxicities from prior therapies
- Incomplete recovery from surgery or active wound healing
- Significant heart disease or unstable angina
- Prolonged QTc interval or abnormal ECG findings
- Difficulty swallowing capsules or gastrointestinal conditions affecting drug absorption
- Uncontrolled illnesses or conditions limiting study compliance
- Any other condition making participation unsuitable in investigator's opinion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 9 locations
1
City of Hope
Duarte, California, United States, 91010
Actively Recruiting
2
Mayo Clinic
Jacksonville, Florida, United States, 32224
Actively Recruiting
3
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
4
Novant Health
Charlotte, North Carolina, United States, 28204
Actively Recruiting
5
Gabrail Cancer Center
Canton, Ohio, United States, 44718
Actively Recruiting
6
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
7
Swedish Health
Seattle, Washington, United States, 98122
Actively Recruiting
8
Princess Alexandria Hospital
Brisbane, Queensland, Australia, QLD 4102
Actively Recruiting
9
Frankston Private Hospital
Melbourne, Victoria, Australia, 3199
Actively Recruiting
Research Team
L
Laura Glass
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here