144 Participants Needed
Ascentage Pharma Group Inc. logo

APG-2575 for CLL

Recruiting in Canton (>99 mi)
+8 other locations
AK
LG
Overseen ByLaura Glass
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Ascentage Pharma Group Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of 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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you cannot take certain medications like strong CYP3A inhibitors or inducers within 7 days before starting the trial.

What data supports the effectiveness of the drug APG-2575 (Lisaftoclax) for treating chronic lymphocytic leukemia (CLL)?

Venetoclax, a drug similar to APG-2575, has shown effectiveness in treating CLL, especially in patients with high-risk features, by achieving significant remission rates and being generally well-tolerated. This suggests that APG-2575, which may work in a similar way, could also be effective for CLL.12345

Who Is on the Research Team?

YZ

Yifan Zhai, MD, PhD

Principal Investigator

Ascentage Pharma Group Inc.

Are You a Good Fit for This Trial?

This trial is for adults over 18 with chronic lymphocytic leukemia (CLL) or small lymphocytic leukemia (SLL) who have tried at least one treatment without success and need more therapy. They should be relatively active (ECOG ≤2), show signs of disease progression, and meet specific blood count and organ function criteria.

Inclusion Criteria

I can take care of myself and am up and about more than 50% of my waking hours.
My platelet count is high enough without needing a transfusion in the past week.
Females of childbearing potential and non-sterile males must practice at least one of the following methods of birth control with partner(s) throughout the study and for 90 days after discontinuing study drug: Total abstinence from sexual intercourse, Surgically sterile partner(s), Intrauterine device (IUD), Double-barrier method, Hormonal contraceptives for at least 3 months prior to study drug administration, Male patients must refrain from sperm donation from initial study drug administration until 90 days after the last dose of study drug, Ability to understand and willingness to sign a written informed consent form, Willingness and ability to comply with study procedures and follow-up examination
See 14 more

Exclusion Criteria

Any other condition or circumstance that would make the patient unsuitable for participation in the study
I have not had radiation therapy in the last 14 days.
I have an active hepatitis B or C infection.
See 18 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Ramp-up

Participants undergo a ramp-up period with APG-2575 starting at 20 mg and increasing to a maximum of 1200 mg over several days

3-9 days

Dose Escalation and Expansion

APG-2575 is studied at different dose levels as monotherapy and in combination with other agents using a 3+3 dose escalation design, followed by dose expansion at RP2D

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • APG2575
Trial Overview The study tests APG-2575 alone or with other treatments to find the safest dose that's still effective for CLL/SLL. It aims to identify any toxic effects at different doses and establish a recommended dosage for future phase 2 trials.
How Is the Trial Designed?
4Treatment groups
Experimental Treatment
Group I: Lisaftoclax 800mgExperimental Treatment1 Intervention
Group II: Lisaftoclax 600mgExperimental Treatment1 Intervention
Group III: Lisaftoclax 400mgExperimental Treatment1 Intervention
Group IV: Lisaftoclax 1000mgExperimental Treatment1 Intervention

APG2575 is already approved in China for the following indications:

🇨🇳
Approved in China as Lisaftoclax for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Ascentage Pharma Group Inc.

Lead Sponsor

Trials
54
Recruited
5,700+

Published Research Related to This Trial

Venetoclax, an oral BCL-2 inhibitor, is an effective long-term treatment for patients with relapsed/refractory chronic lymphocytic leukemia (CLL), particularly those with high-risk features like chromosome 17p deletion, based on a safety analysis of 350 patients.
The treatment is generally well tolerated, with manageable side effects; however, common adverse events included diarrhea (41%), neutropenia (40%), and nausea (39%), and serious infections occurred in 15% of patients, indicating the need for monitoring during therapy.
Comprehensive Safety Analysis of Venetoclax Monotherapy for Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia.Davids, MS., Hallek, M., Wierda, W., et al.[2019]
A middle-aged female patient with poor prognosis unmutated IGHV chronic lymphocytic leukemia (CLL) achieved complete cytogenetic and molecular remission after six cycles of low-dose recombinant human IL-2 combined with low-dose venetoclax, indicating the treatment's efficacy.
The combination therapy of low-dose rIL-2 and venetoclax is a non-toxic immunotherapy that stimulates natural killer cells, making it a promising outpatient treatment option for patients with poor prognosis CLL.
Molecular Remission Using Low-Dose Immunotherapy with Minimal Toxicities for Poor Prognosis IGHV- Unmutated Chronic Lymphocytic Leukemia.Maharaj, D., Srinivasan, G., Abreu, MM., et al.[2021]
The German CLL Study Group is focusing on developing optimal, non-toxic drug combinations for chronic lymphocytic leukemia (CLL) therapy, utilizing novel agents like bendamustine, idelalisib, and ibrutinib.
Phase II combination trials (BXX series) are underway to evaluate the effectiveness of these combinations, aiming to improve treatment outcomes for CLL patients.
Current strategies to create tailored and risk-adapted therapies for CLL patients.Cramer, P., Eichhorst, B., Reinhardt, HC., et al.[2021]

Citations

Comprehensive Safety Analysis of Venetoclax Monotherapy for Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia. [2019]
Molecular Remission Using Low-Dose Immunotherapy with Minimal Toxicities for Poor Prognosis IGHV- Unmutated Chronic Lymphocytic Leukemia. [2021]
Current strategies to create tailored and risk-adapted therapies for CLL patients. [2021]
BCL-2 as a therapeutic target in chronic lymphocytic leukemia. [2017]
Venetoclax for patients with chronic lymphocytic leukemia who progressed during or after idelalisib therapy. [2021]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security